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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Ingenuity TF	882442	FDA UDI	Class II	Unknown
Philips	459801050601	FDA UDI	Class II	Unknown
Philips	459801630821	FDA UDI	Class II	Active
Philips	459801419352	FDA UDI	Class II	Unknown
Philips	459801050602	FDA UDI	Class II	Unknown
Pinnacle Radiation Therapy Planning System	18.0	FDA UDI	Class II	Active
Ingenuity Flex	728317	FDA UDI	Class II	Unknown
Edge/Vista System Enhancement Package	K964626	FDA 510(k)	Class II	Active
Uhe Collimator (210591)	K963406	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K885047	FDA 510(k)	Class II	Active
Vista Hpq System	K921881	FDA 510(k)	Class II	Active
Beacon, Model 211060	K983948	FDA 510(k)	Class II	Active
Blood Oxygenation Level Dependent (bold) Option	K010691	FDA 510(k)	Class II	Active
System 400	K810973	FDA 510(k)	Class II	Active
Cervix Coil Latex Sheath	K981406	FDA 510(k)	Class II	Active
Voyager 6.0 Software Option	K000310	FDA 510(k)	Class II	Active
Gemini Gxl	K042935	FDA 510(k)	Class II	Active
Odyssey Lx, Model 211320	K003437	FDA 510(k)	Class II	Active
Head/Neck Vascular Phased Array Coil Package	K952530	FDA 510(k)	Class II	Active
Philips Mx 16 Slice Ct System Phase11, Model 9896 056 56511	K091195	FDA 510(k)	Class II	Active
Lcr Generator	K931998	FDA 510(k)	Class I	Active
Viewpoint	K961168	FDA 510(k)	Class II	Active
Brain Perfusion Option	K033677	FDA 510(k)	Class II	Active
Pace-4-Automatic Ria Gamma-Couter	K802578	FDA 510(k)	Class I	Active
Mr Spectroscopy Package	K991568	FDA 510(k)	Class II	Active
Microview	K790489	FDA 510(k)	Class II	Active
Edge	K941996	FDA 510(k)	Class II	Active
Gemini Gxl	K051170	FDA 510(k)	Class II	Active
Ls1000 Electronic Focus	K810118	FDA 510(k)	Class II	Active
Quantitative Flow	K992225	FDA 510(k)	Class II	Active
Jetpack 2.0	K111024	FDA 510(k)	Class II	Active
0.5 T Compact Magnet For Its Vista Mr 2055 Hp Syst	K883520	FDA 510(k)	Class II	Active
Cap-Mobile	K781425	FDA 510(k)	Class II	Active
Nrf System	K944973	FDA 510(k)	Class II	Active
Multi-Format Sfd Model 1720	K800554	FDA 510(k)	Class II	Active
Hitachi Tech-Moble Dhc-121	K780313	FDA 510(k)	Class II	Active
Orbitome-Ug	K780319	FDA 510(k)	Class II	Active
Philips CT Big Bore Sliding Gantry Configuration	K181797	FDA 510(k)	Class II	Active
Vista Mr 2055 Hp System	K895151	FDA 510(k)	Class II	Active
Gemini Condor	K081135	FDA 510(k)	Class II	Active
Allegro Imaging System	K033782	FDA 510(k)	Class II	Active
Fv-Rf	K984111	FDA 510(k)	Class II	Active
Jpacs	K980918	FDA 510(k)	Class I	Active
Viewpoint Passive Tool Option	K990868	FDA 510(k)	Class II	Active
Linear Array Scanner	K800805	FDA 510(k)	Class II	Active
Electrocardiograph Cm3000	K813279	FDA 510(k)	Class II	Active
Philips Model Mx 16 Slice Ct System	K083498	FDA 510(k)	Class II	Active
Merit (o.1t Mr System)	K943415	FDA 510(k)	Class II	Active
Ebw Nm 2.0	K111336	FDA 510(k)	Class II	Active
General Purpose Flex Coil	K944469	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.