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Philips Medical Systems (Cleveland), Inc.

United States·US-MF-000008701

Last updated September 17, 2026

Information

Country: United States
Address: 3630, SW 47th Ave, Gainesville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Vered Nitzan
EUDAMED SRN: US-MF-000008701
FDA FEI Number: 3018004899
DUNS Number: —

Catalogue (198)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Vista Mr 2055 Hp System	K893619	FDA 510(k)	Class II	Active
Fast And Ce-Fast Mri Sequences (for Nmr 1000)	K883519	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K903048	FDA 510(k)	Class II	Active
Bucky Wall Stand	K781473	FDA 510(k)	Class II	Active
Dyna- Mo	K811629	FDA 510(k)	Class I	Active
Viewpoint Tools- Sterrad	K983764	FDA 510(k)	Class II	Active
Facts	K982010	FDA 510(k)	Class II	Active
Powerdrive 350 Option	K002415	FDA 510(k)	Class II	Active
Philips Ingenuity CT	K160743	FDA 510(k)	Class II	Active
Preference Mammography System	K945743	FDA 510(k)	Class II	Active
Iso-Mammo	K860129	FDA 510(k)	Class II	Active
Pinpoint	K974513	FDA 510(k)	Class II	Active
1.5t Edge And 1.0t Vista Systems	K931544	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K883378	FDA 510(k)	Class II	Active
Vistar	K905070	FDA 510(k)	Class II	Active
Dss 500	K811934	FDA 510(k)	Class II	Active
Infinion 0.6t Mr Imaging System	K013858	FDA 510(k)	Class II	Active
Asset Apollo	K971884	FDA 510(k)	Class II	Active
Model Dh-1000 Single Detec./Dual Detec Nucl Camera	K904050	FDA 510(k)	Class I	Active
Cx250 Mobile Gamma Camera & Dcs Console	K880878	FDA 510(k)	Class I	Active
Mr Guided Procedures (mrgp) Basic Package	K983342	FDA 510(k)	Class II	Active
Mx8000 V5.0 Ct System	K010817	FDA 510(k)	Class II	Active
Uro - Elite Table Accessories	K944987	FDA 510(k)	Class II	Active
Flexible Phased Array Spine Coil	K960497	FDA 510(k)	Class II	Active
Outlook	K945827	FDA 510(k)	Class II	Active
Pq5000 Ct System	K943623	FDA 510(k)	Class II	Active
Merit	K933356	FDA 510(k)	Class II	Active
Brilliance Dual Energy Option	K090462	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K883482	FDA 510(k)	Class II	Active
Step Option To Prism 2000	K960865	FDA 510(k)	Class II	Active
Pq-2000+ Computed Tomography X-Ray System	K955268	FDA 510(k)	Class II	Active
Viewpoint - 3.0 Software	K970604	FDA 510(k)	Class II	Active
Epi-Scope Option For Q Series Ct Systems	K962010	FDA 510(k)	Class II	Active
Vector-100 X-Ray Generator	K802996	FDA 510(k)	Class I	Active
Phased Array Neck Coil	K964678	FDA 510(k)	Class II	Active
Acqsim Simulator/Localizer	K923851	FDA 510(k)	Class II	Active
Acqsim-Multislice-Ct, Model 453567042271	K033357	FDA 510(k)	Class II	Active
Philips Multislice CT System with Low Dose CT Lung Cancer	K153444	FDA 510(k)	Class II	Active
Dsp Option	K945580	FDA 510(k)	Class II	Active
Vista Hpq System	K905259	FDA 510(k)	Class II	Active
Sense Body Coil	K031095	FDA 510(k)	Class II	Active
Viewpoint Ent/Orthopedic Option	K991256	FDA 510(k)	Class II	Active
Synerview Model 6478	K770855	FDA 510(k)	Class II	Active
Lung Nodule Assessment And Comparison Option	K023785	FDA 510(k)	Class II	Active
Medex X-Ray Table	K854328	FDA 510(k)	Class II	Active
Universal Abc Controler	K883580	FDA 510(k)	Class II	Active
Epi-Ii System Option W/High Performance Gradients	K954646	FDA 510(k)	Class II	Active
Low Dose Servochest	K810797	FDA 510(k)	Class II	Active
Scanner, Linear	K781709	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K896508	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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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
Aug 5, 2025	Z-2570-2025	—	open, classified	Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Jul 17, 2025	Z-2239-2025	—	open, classified	Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Aug 30, 2022	Z-1744-2022	—	open, classified	When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
Sep 19, 2019	Z-0215-2020	—	terminated	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Z-0213-2020	—	terminated	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Z-0217-2020	—	terminated	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Z-0216-2020	—	terminated	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Z-0214-2020	—	terminated	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Jun 24, 2019	Z-2186-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2188-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2192-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2189-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2193-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2190-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2194-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2187-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 24, 2019	Z-2191-2019	—	terminated	In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Jun 10, 2019	Z-2010-2019	—	terminated	An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Jun 10, 2019	Z-2011-2019	—	terminated	An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Jun 10, 2019	Z-2009-2019	—	terminated	An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Jun 3, 2019	Z-1929-2019	—	terminated	The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.
Dec 19, 2018	Z-0823-2019	—	terminated	A software update is being issued to correct multiple issues identified in the previous software version.
Oct 18, 2018	Z-0544-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Oct 18, 2018	Z-0548-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Oct 18, 2018	Z-0545-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Oct 18, 2018	Z-0547-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Oct 18, 2018	Z-0543-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Oct 18, 2018	Z-0546-2019	—	terminated	There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Sep 4, 2018	Z-0302-2019	—	terminated	Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.
Jul 3, 2018	Z-1143-2019	—	terminated	Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Jul 3, 2018	Z-1144-2019	—	terminated	Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Jul 3, 2018	Z-1142-2019	—	terminated	Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
May 21, 2018	Z-2496-2018	—	terminated	The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
Mar 30, 2018	Z-2174-2018	—	terminated	The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Mar 30, 2018	Z-2175-2018	—	terminated	The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Mar 30, 2018	Z-2176-2018	—	terminated	The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Mar 28, 2018	Z-2277-2018	—	terminated	A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Mar 28, 2018	Z-2274-2018	—	terminated	A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Mar 28, 2018	Z-2273-2018	—	terminated	A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Mar 28, 2018	Z-2275-2018	—	terminated	A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Mar 28, 2018	Z-2276-2018	—	terminated	A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Feb 21, 2018	Z-1396-2018	—	terminated	Surview scan with tube current lower than 30 mA is unable to be initialized.
Feb 15, 2018	Z-1392-2018	—	terminated	Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Feb 8, 2018	Z-1414-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1408-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1415-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1409-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1405-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1411-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1410-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1406-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1407-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1413-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1412-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Feb 8, 2018	Z-1404-2018	—	terminated	Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Jan 11, 2018	Z-0841-2018	—	terminated	23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Jan 3, 2018	Z-0839-2018	—	terminated	Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Jan 3, 2018	Z-0840-2018	—	terminated	Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Dec 15, 2017	Z-0512-2018	—	terminated	During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Dec 15, 2017	Z-0514-2018	—	terminated	During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Dec 15, 2017	Z-0510-2018	—	terminated	During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Dec 15, 2017	Z-0513-2018	—	terminated	During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Dec 15, 2017	Z-0511-2018	—	terminated	During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Dec 11, 2017	Z-0562-2018	—	terminated	A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message Result {0} failed to reconstruct" on the Acquisition Workflow window during reconstruction after the patient scan has been completed. In both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
Nov 10, 2017	Z-0390-2018	—	terminated	Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Nov 10, 2017	Z-0389-2018	—	terminated	Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Nov 10, 2017	Z-0388-2018	—	terminated	Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Nov 10, 2017	Z-0391-2018	—	terminated	Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Nov 8, 2017	Z-0332-2018	—	terminated	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Nov 8, 2017	Z-0333-2018	—	terminated	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Nov 8, 2017	Z-0331-2018	—	terminated	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Nov 1, 2017	Z-0522-2018	—	terminated	One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Oct 6, 2017	Z-0518-2018	—	terminated	Numerous issues related to software Brilliance iCT 4.1.6 software version.
Oct 6, 2017	Z-0520-2018	—	terminated	Numerous issues related to software Brilliance iCT 4.1.6 software version.
Oct 6, 2017	Z-0519-2018	—	terminated	Numerous issues related to software Brilliance iCT 4.1.6 software version.
Oct 6, 2017	Z-0521-2018	—	terminated	Numerous issues related to software Brilliance iCT 4.1.6 software version.
Jul 11, 2017	Z-0402-2018	—	terminated	Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Jul 11, 2017	Z-0403-2018	—	terminated	Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Jun 7, 2017	Z-0311-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0308-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0303-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0307-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0304-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0309-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0310-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0305-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Jun 7, 2017	Z-0306-2019	—	terminated	It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Feb 24, 2017	Z-1750-2017	—	terminated	The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Feb 24, 2017	Z-1751-2017	—	terminated	The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Feb 24, 2017	Z-1752-2017	—	terminated	The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Feb 24, 2017	Z-1753-2017	—	terminated	The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Feb 23, 2017	Z-1493-2017	—	terminated	Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Feb 23, 2017	Z-1492-2017	—	terminated	When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Jan 31, 2017	Z-1480-2017	—	terminated	Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Jan 31, 2017	Z-1481-2017	—	terminated	Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Jan 31, 2017	Z-1479-2017	—	terminated	Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Dec 23, 2016	Z-1186-2017	—	terminated	The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Dec 23, 2016	Z-1187-2017	—	terminated	The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Dec 23, 2016	Z-1058-2017	—	terminated	During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Dec 16, 2016	Z-1006-2017	—	terminated	Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.