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Philips Medical Systems

United States·US-MF-000002128

Last updated June 8, 2026

Information

Country: United States
Address: 22100, Bothell Everett Highway, Bothell, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: —
EUDAMED SRN: US-MF-000002128
FDA FEI Number: —
DUNS Number: —

Catalogue (488)

Page 5 of 10

Device	Model / Reference	Registries	Class	Status
Heartstream/Heartstart Fr2 Aed Ecg Cable, Models M3860a, M3861a, M3840a, M3841a	K013425	FDA 510(k)	Class III	Active
Philips Heartstart Smartpads Iii	K072812	FDA 510(k)	Class III	Active
Digital Spot Imaging (dsi)	K893131	FDA 510(k)	Class II	Active
M3290a Intellivue Information Center Software Release F.o And The M4840a Telemetry Monitoring System Ii	K040357	FDA 510(k)	Class II	Active
Suresigns Vs3, Suresigns Vs4	K133961	FDA 510(k)	Class II	Active
Philips Medical Systems, M3012a- Hemodynamic Extension To The Multi-Measurement Server	K033444	FDA 510(k)	Class II	Active
Suresigns Vm4, Suresigns Vm6, Suresigns Vm8	K123900	FDA 510(k)	Class II	Active
Suresigns Vs2+ -suresigns Vsi	K112652	FDA 510(k)	Class II	Active
Philips Dxl 12/16-Lead Ecg Algorithm	K132068	FDA 510(k)	Class II	Active
Suresigns Vs3 Vital Signs Monitor, Suresigns Vs4 Vital Signs Monitor	K120132	FDA 510(k)	Class II	Active
Philips Heartstart Fr3 Automated External Defibrillator	K111693	FDA 510(k)	Class III	Active
Philips Gyroview-Hr Imaging Workstation	K905603	FDA 510(k)	Class II	Active
Suresigns Vm4, Suresigns Vm6, Suresigns Vm8 Model: 863063, 863064, 863065, 863066, 863068	K101067	FDA 510(k)	Class II	Active
Pics-2000	K880822	FDA 510(k)	Class II	Active
Philips Easyvision	K953911	FDA 510(k)	Class II	Active
Hearstart Mrx With Airway Confimration Assist	K130153	FDA 510(k)	Class III	Active
Philips Cardiac Workstation	K922622	FDA 510(k)	Class II	Active
Intellivue Mx40 Patient Monitor	K103646	FDA 510(k)	Class II	Active
Sursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient Monitors	K090483	FDA 510(k)	Class II	Active
Sl Series, Sl 15, 18, 20 & 25 (modification)	K882231	FDA 510(k)	Class II	Active
Sri 100 Radiotherapy Imaging System	K894912	FDA 510(k)	Class II	Active
Philips Veriflex	K902849	FDA 510(k)	Class II	Active
Philips Gyroscan Tn5 & Tn5 Lite	K932644	FDA 510(k)	Class II	Active
Philips Sli Series Linear Accelerator	K963624	FDA 510(k)	Class II	Active
M2376a Devicelink System	K030731	FDA 510(k)	Class II	Active
Philips Gyroscan Tn 15	K932645	FDA 510(k)	Class II	Active
Philips Drug Calculator Software	K023674	FDA 510(k)	Class II	Active
Antimicrobial And Single-Patient Cuffs	K071885	FDA 510(k)	Class II	Active
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System	K211597	FDA 510(k)	Class II	Active
Vericord S3	K894123	FDA 510(k)	Class II	Active
M3290a Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)	K062271	FDA 510(k)	Class II	Active
Easi 12 Lead Algorithm	K020456	FDA 510(k)	Class II	Active
M3290a Intellivue Information Center Software Release E.01 And Intellivue Clinical Network On Vlan	K040955	FDA 510(k)	Class II	Active
SureSigns VS3; SureSigns VS4	K163649	FDA 510(k)	Class II	Active
M3290B Patient Information Center iX	K183387	FDA 510(k)	Class II	Active
6.0 Mhz La6060 Transducer & 4.0 Mhz La4011 Transdu	K844772	FDA 510(k)	Class II	Active
Philips Heartstart Fr3 Automated External Defibrillator	K130684	FDA 510(k)	Class III	Active
Philips Medio Cp Family	K925105	FDA 510(k)	Class I	Active
Tomoscan Lx Computed Tomography System	K882022	FDA 510(k)	Class II	Active
The M3810a Philips Telemonitoring System With M3814a Spo2 Unit	K041674	FDA 510(k)	Class II	Active
Heartstart Xl+defibrillator/Monitor With End-Tidal Carbon Dioxide Monitoring	K133659	FDA 510(k)	Class III	Active
Philips Page Writer Trim Series Cardiograph Including I, Ii, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291	K031422	FDA 510(k)	Class II	Active
Philips Tomoscan Sr7000 Ct Systems	K924082	FDA 510(k)	Class II	Active
Philips 12-Lead Algorithm	K052049	FDA 510(k)	Class II	Active
Philips Component Compact Monitor, Model M1275b, Philips Compenent Rack, Model M1276b	K013199	FDA 510(k)	Class II	Active
Patient Monitors Various Models	K151812	FDA 510(k)	Class II	Active
Pcr Eleva 1.2	K093355	FDA 510(k)	Class II	Active
Philips Compurecord Peri-Operative Information System Software	K030939	FDA 510(k)	Class II	Active
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph	K191738	FDA 510(k)	Class II	Active
Heartstart Mrx, Model M3535a	K031187	FDA 510(k)	Class III	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 7, 2026	Z-1825-2026	—	open, classified	Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Sep 25, 2025	Z-0377-2026	—	open, classified	Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Sep 25, 2025	Z-0375-2026	—	open, classified	Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Sep 25, 2025	Z-0376-2026	—	open, classified	Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Dec 13, 2023	Z-1055-2024	—	open, classified	A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Dec 13, 2023	Z-1054-2024	—	open, classified	A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Feb 11, 2022	Z-1088-2024	—	open, classified	While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Feb 11, 2022	Z-1087-2024	—	open, classified	While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Aug 24, 2016	Z-0011-2017	—	terminated	The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Aug 24, 2016	Z-0010-2017	—	terminated	The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Aug 24, 2016	Z-0009-2017	—	terminated	The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Aug 24, 2016	Z-0012-2017	—	terminated	The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Jan 8, 2016	Z-0745-2016	—	terminated	In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
Apr 23, 2015	Z-1643-2015	—	terminated	A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si
Feb 9, 2015	Z-1554-2015	—	terminated	The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
Feb 9, 2015	Z-1555-2015	—	terminated	The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
Feb 3, 2015	Z-0352-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0347-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0349-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0346-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0348-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0350-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0354-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0351-2016	—	terminated	Monitor Ceiling Suspension system may fall
Feb 3, 2015	Z-0353-2016	—	terminated	Monitor Ceiling Suspension system may fall
Jan 23, 2015	Z-1251-2015	—	terminated	Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.
Dec 23, 2014	Z-0219-2016	—	terminated	MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed
Dec 19, 2014	Z-0374-2016	—	terminated	Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Nov 20, 2014	Z-1307-2015	—	terminated	VCG battery ignited in a VCG unit when recharging.
Nov 19, 2014	Z-0204-2016	—	terminated	1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Nov 19, 2014	Z-0997-2015	—	terminated	Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.
Nov 19, 2014	Z-0262-2016	—	terminated	MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Nov 19, 2014	Z-0963-2015	—	terminated	Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Oct 10, 2014	Z-0206-2015	—	terminated	Mold on gel filled Gel-E and Squishon products
Oct 3, 2014	Z-0104-2015	—	terminated	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Oct 3, 2014	Z-0105-2015	—	terminated	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Sep 24, 2014	Z-1280-2016	—	terminated	Loss of key image functionality due to a bent pedal of the Footswitch.
Sep 24, 2014	Z-1279-2016	—	terminated	Loss of key image functionality due to a bent pedal of the Footswitch.
Aug 21, 2014	Z-0325-2016	—	terminated	When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
Aug 19, 2014	Z-0365-2016	—	terminated	The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Aug 19, 2014	Z-0364-2016	—	terminated	The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Aug 8, 2014	Z-0022-2015	—	terminated	Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Aug 7, 2014	Z-2535-2014	—	terminated	Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
Jul 31, 2014	Z-0236-2015	—	terminated	It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Jul 8, 2014	Z-0181-2015	—	terminated	Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Jul 8, 2014	Z-0182-2015	—	terminated	Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Jun 13, 2014	Z-1864-2014	—	terminated	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Z-1865-2014	—	terminated	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Z-1863-2014	—	terminated	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 13, 2014	Z-1862-2014	—	terminated	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Jun 6, 2014	Z-1120-2015	—	terminated	In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
May 22, 2014	Z-1746-2014	—	terminated	IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
May 15, 2014	Z-1827-2014	—	terminated	Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
May 15, 2014	Z-1826-2014	—	terminated	Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
May 5, 2014	Z-0135-2016	—	terminated	In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
Apr 8, 2014	Z-0508-2015	—	terminated	In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
Apr 4, 2014	Z-1628-2014	—	terminated	The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
Apr 2, 2014	Z-1495-2014	—	terminated	Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
Apr 2, 2014	Z-1438-2014	—	terminated	Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
Mar 31, 2014	Z-1439-2014	—	terminated	A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Mar 17, 2014	Z-1503-2014	—	terminated	The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
Feb 18, 2014	Z-1120-2014	—	terminated	Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
Feb 18, 2014	Z-1118-2014	—	terminated	ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
Feb 18, 2014	Z-1194-2014	—	terminated	When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
Feb 18, 2014	Z-1108-2014	—	terminated	Wireless Link may be unable to transmit data when configured for a specific data flow.
Feb 18, 2014	Z-1155-2014	—	terminated	MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
Feb 18, 2014	Z-1090-2014	—	terminated	A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
Feb 14, 2014	Z-1109-2014	—	terminated	Philips HeartStart XL may experience a power board failure causing failure to defibrillate
Feb 4, 2014	Z-1110-2014	—	terminated	HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
Jan 24, 2014	Z-1107-2014	—	terminated	HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling
Dec 10, 2013	Z-0570-2014	—	terminated	MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
Dec 5, 2013	Z-0584-2014	—	terminated	X-ray system C-arm casting may loosen and fall
Oct 30, 2013	Z-0431-2014	—	terminated	The delivered application software was an outdated version to the model of equipment.
Oct 23, 2013	Z-0203-2015	—	terminated	It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
Oct 14, 2013	Z-1044-2015	—	terminated	The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Oct 14, 2013	Z-1045-2015	—	terminated	The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Jun 7, 2013	Z-0593-2014	—	terminated	Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10
Apr 10, 2013	Z-0613-2014	—	terminated	Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
Dec 8, 2011	Z-0607-2012	—	terminated	During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner.
Sep 27, 2011	Z-0247-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0254-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0249-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0250-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0252-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0248-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0257-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0256-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0255-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0258-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0253-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 27, 2011	Z-0251-2012	—	terminated	A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Sep 15, 2011	Z-0182-2012	—	terminated	A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.
Jun 15, 2011	Z-2947-2011	—	terminated	Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
Jun 15, 2011	Z-2949-2011	—	terminated	Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
Jun 15, 2011	Z-2948-2011	—	terminated	Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
Jun 3, 2011	Z-2871-2011	—	terminated	The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
Jun 3, 2011	Z-2869-2011	—	terminated	The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
Jun 3, 2011	Z-2872-2011	—	terminated	The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
Jun 3, 2011	Z-2870-2011	—	terminated	The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
Jun 3, 2011	Z-2867-2011	—	terminated	The gap between the two parts of the table may permit pinches to occur on either patients skin or other body parts; it has the potential for serious injury if a patients finger is caught between the pallet and patient table resulting in broken finger bone.