FDAFDA · Food and drugs·Recall number Z-3214-2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Published October 2, 2024 · Recall initiated: August 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare
- Distributor
- Worldwide distribution.
- Lot
- All versions of Centricity PACS: V2, UDI/DI Not Applicable; V3, UDI/DI Not Applicable; V4, UDI/DI 00840682124430; V6, UDI/DI 00840682104807; V7, UDI/DI 00840682145572 installed on the following systems: CARTI02312611, CARTI22214087T, 501268SSASW, 501268SSATSW, 928757VPASW, 928757VPBSW, 928757VPTSW, 602344PVSW2, 602344REPSITEB, MARICOPAC02308029, 602344TIMSVM, 480323PVSW, 661633PVSW, 805395PVSW, 805395PVTSW, V5SPORTS01804913, 310349PACSSWPV, UCLAMC2259090, 310349PACSSWBPV, UCLAMC2259063, 831624PVASW, UHSD02184496, 916781CPACSSRWT, PALMDALEM01810792, PALMDALEM16023955, UHSD16084343, PALMDALEM20508297, PALMDALEM21178954, MHL02186470, 909788HCAPACS1, 916781CPACSCKS, 916781CPACSBCKS, 650696PACSEESW, MPHS2259091, GSHCACPSW, GSH320037250, VSMY01820423, 209532SESW, SONORAREG19607823, RANCHO02255039, RANCHOPISU2, RANCHOPTESTISU, To be Provided , 805370HCALR, VMPACS69, LOSROBLES19666790, SOUTHWEST01815383, MCANPACSW, MCASPACSW, CENPACSW, 303329HCAPSWS, 303584HCAPVSW, 303584REPBSW, 303584HCAPVSWTESTIMS, SRMCPACSW, 719584VPSW, PKV2259020, 719584VPBSW, NSMCPACSW, 970476PVSW, VVMC15111181, 302674PACSSW, 302674PACSBSW, 302736SAEATSW, JFKSW, JFKR19980220B, INFINITYW01452121, 727462PVSW, 727462PVBSW, MPMH2259089T, 772461HCAPACSW, 772461HCAPACSW1, 772461HCAPACSWT, FWMCCPTSW, 352333PACSSW, NFRH19663978B, 904202BMCDSW, 904202BMCSSW, MJPACSW, MJPACTSW, 904202BMCDTSW, BIHT20915070-IMSTest2, BIHT20915071-IMSTEST4x, 407518COREPACS, HH1001398036, 407518CPREPB, 863680PVSW, KRMCOREPACSSW, KRMC19478073, 407888HCASWSS, 615344HCASW, PCMC420084442, 561694CAPACSSW, WFLHIV01, WESTFLORI19661467, 772335PACSSW, 772335PVSW, 941637PVSW, 941637TIMS90, 850875PVSW2, 904819PVSW, 904819PV2SW, 904819PVTSW, 727519PVBSW, 850325PACSCORE, CRMC820084433, 888663CPBSW, USFIMSSSASW, 727519PVSW, VSMAE01817090, NGDC01893569, 888663CPTSW, 888663CPB2SW, USFIMSSSABSW, USFIMSSSATSW1, USFIMSSSATSW2, 727519PVMSW, 727519PVTSW, VAMAF02345966, VSMI18957442DCC, 407518SCPACSHC, 850325HCASWOPT, WFLHIVT01, PCMC42259036, 352333PACSTSW, VSMAM02004646, WELLINGTON01810730, UHSD02289750, WELLINGTON19678279T, WELLINGTON20036598, TRMPACSW, TRMNC20021605, 100115-8-Centricity PACS-21222171, TRMTESTPACS, Doctors Ho22222417, 407772CORESW, 404605PVBSW, 404851PVSW, 404851PVTSW, 404851PVBSW, 404605PVTSW, 407772COREBSW, 407772CORETSW, 706651HCACORE, 912466PVSW, SGHS2259039, 912276PVSW, 912276PVTSW, 706278PACSSWPV, 706278PACSSWBPV, 706278PACSSWTPV, 404501PACSSWPV, 404501PACSSWBPV, 404501PACSSWATPV, 404501PACSSWBTPV, 706754PACSSW, 404605PVSW, 478633PACSSWPV, MCG2259011, MCG20084728, VSMQL01987331, 404325PACSSWPV, 404325PACSSWBPV, 404325PACSTSW, 406238PVSW, VSMZ01812192, 641422PVSW, PROSPECT2259057, PROSPECT2259084, PROSPECT22128566, 319272SCPSWULP, 319272CPDRSW, 319272CPDRBSW, 319272SCPTSWULP, 208COREPVSW, EID19660790, 208CORETIMS, 208743PVSW, 208743PVTSW, 847NWCPVSW, 847NWCPVSW2, 773880PVSW, 795079PACSEESW1, 795079PACSEESW2, 312926PACSSWPV, 312996PVSW2, JSHPACSSW, 312996PVSW1, 312996PVSWT1, 312996PVSWT2, 795079PACST, JHSJHOCC02259030, 773880PVBSW, 773880PVTSW, JSHPACSTSW, 217876PVSW, 217876PVBSW, 815285PACUV100, 630963PVSW, ADVPACSTSW1, 847437PVSW, 847437DCPVSW, 847437SAPVTSW, 847990PVSW, S046PACSSWPV, S801PACSSWPV, S046PACSSWTPV, ADVPACSSW, ADVPACSBSW, ADVPACSTSW, 815398CPACSSW, 219325PVSW1, 219325PVBSW1, 219325PVTSW1, 765983PVSW, 765983PVSW2, RHHCS02253964T, 812232PACSPV, 812232PACSTPV, 812232PACS2PV, THRH20084364, FRNKHAPACSPV, FRNKHAPACSTPV, FRANKFORT19633100, RRMCPACSW, RGMCPACSTW, RRMC120080697, VTP01810617T, VHT02334235P, VTP19617532, 985867CORESW, 985230PVSW, NOMC2259032, CFO18227240, 985230PVSWS, 504903CPACSSW, 504988SSASW, 504903CPACSTSW, 504988SSATSW, MCOLANO20039031, HTMC20085961, 504903CPACSIMS, 617638SSASW, 617638SSBSW, 617638SSATSW, 781979PVSW, 781979PVBSW, 781979PVTSW, 413447BCPVSW, 413447HCPVSW, 413447PVSW, 413748PVSW, 413748PVTSW, 413748PVBSW, 301698PVSW, 301698PVTSW, NORTHE02315652, NORTHE02370307T, 207795PVSWC3, 207795PVSWC1, 207795PVSWC2, 517353PACSEESW, 517353PACSEETSW, 906387VPSW
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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