GE Healthcare: GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 2138 units Lot/code info: 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,

UPC codes

00840682124430, 00840682104807, 00840682145572, 082499110172, 082499310155, 082455210055, 082455150052, 082455160221, 082455160134, 082499180109, 082499180102, 082455160255, 082427190180, 082445110005, 082403010015, 082455190146, 082499130790, 082499130125, 082499020074, 082455040339, 082407040684, 082455040204, 82455040334, 082499040230, 082455040337, 082455040147, 082455040274, 082455040352, 082445040028, 082455040317, 082499110183, 082455190147, 82499220115, 082499100382, 082455150074, 082455150068, 082455150039, 082455180040, 082499180080, 082455170088

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.