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GE Healthcare, LLC Recall 88526

Description: Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

GE Healthcare, LLC Recall 88526 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2503-2021
Event ID88526
Event DescriptionCentricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Product TypeDevices
DistributionAK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.
Quantity392 (219 US; 173 OUS)
Recall ReasonImage acquisition failures and synchronization failure with the Centricity Enterprise Archive
Device Classification20210929
Device Code Info2090255-001 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1) System ID: 01977813, 01980259, 06051PAC04, 083055800046112, 083055820116113, 083055824999515, 083055861021012, 1-103108035, 1-142022244, 1-182669905, 1-218291079, 1-219095008, 124774CS01, 1-276423210, 1-283596904, 1-283597082, 1-357059471, 1-375705893, 1-382753509, 1-464783615, 1-473998727, 1-486091448, 1-486091475, 1509505, 1-592001096, 1-598891598, 1-644600677, 1-750710672, 1-802428413, 20101378UBSW, 201392UVSW, 228493WS01, 233638UV01, 416813TESTRPACSUV, 416813UV, 427990UV01, 434487SV03, 482896SV03, 505368UVBSW, 509940UV01, 516473UVSW, 519264PACSAW1, 531344PC01, 600062UV, 600101RW02, 600105ID03, 600791PC02, 786787SV02, 802030PC01, 81111DBS01, 83055862088813, 918277CVUWBSW, 951737IWUWWN1, 954688UVBSW100, A5412010, A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271, A5992711, A6197102, A9190177, ACP00558109, ACP01613226, AH0106SV03, AH0116SV03, AH4325SV01, ALLG00558571, AMS3963, ANCL00558570, ANCL02157634, AP6264PC01, AVHL02396026, AVHL02396027, AVHL02396028, AVHL02396029, AVHL02396030, BARRETTHO00558704, BARRETTHO17737529, BMC12N01271417N1, BMC12P00558644P1, BMC12T02267839, BOJC00558520, BON0164, BVH00558643, BWH01301357, CAROCOMMU01459013, CAROCOMMU02205222, CC4105PC02, CENTERFOR01627896, CENTERFOR16023960UVProxy, CITRUSVAL19618406, CORONAREG01300927, CORONAREG02288447, CSPA01291589, CSPA02097167, DDNI14776603, DHOL19603374, DHOL19603375, DISSFHW01, DP760316, E4167658, ECT0265, EXC01584099, EXC02189547, FORTDUNCA01298556, FORTDUNCA02395799, FP502804, GGMC02349137, GH1077UV01, GTEC01477447, GTEC01477448, GTEC15993728UVProxy3, GZMG02182469CNTRLR, GZMG02287985, GZMG02288300, HANN16174584UVProxy, HANNIBALR02179353, HARTSDALE14768195, HBON01SV02, HC0245PC02, HC0399UV01, HC0529PC01, HC0529PC01, HC0565PC03, HC4105PC01, HCIT4133734PACS, HCIT4192962UV, HCIT4261024UVCTRL, HCIT4264206UW, HCIT4470563UV-CTRL, HCIT7113573UV, HGS01766912, HOA01451973, HOOO20091140, HZC14961014, ICA01367198, ICA14776604, IL1469IT05, ILCC01373579 ILCC14580319, INTERCOAST17594527UVProxy, JKS01452133, JKS14776447UVSFNode, JKS14776448UVProxy, JKS14776449UVTest, JOHNTMA19732280T, KDH217192544, KW0000PP02, LAKESIDEM02256808, LSFH02032334, M41980107, M4487535, M44997011, MARYLANDF17985489, MCT02277843, MCT02278145, MDHC16204735UVProxy, MFCI01448329, MFHO14767332, MGMC02288391, MGMC02398531, MHOG01806096, MINNETOHE, MPX35219, MTGD00558454, MTGD02393053, MYRTLEHIL01444483, NASONHOSP14898835, NCDC20279342, NNAR14767799, NRVM19609993UVT, NRVM19611189UVPROXY, NSW01452088, NSW20080545, OGAA02373799NOD1, OKOS14767330, PACS-IW-129, PACS-IW-1511, PACS-IW-154UV, PACS-IW-166, PACS-IW-166T, PACS-IW-176, PACS-IW-176UVTEST, PACS-IW-181, PACS-IW-189, PACS-IW-202, PACS-IW-202TEST, PACS-IW-219, PACS-IW-225, PACS-IW-230, PACS-IW-253, PACS-IW-255, PACS-IW-318, PACS-IW-31Test, PACS-IW-31Test1, PACS-IW-336, PACS-IW-348UV, PACS-IW-349, PACS-IW-370, PACS-IW-386UV, PACS-IW-389, PACS-IW-390, PACS-IW-402, PACS-IW-405, PACS-IW-406, PACS-IW-419, PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, PACS-IW-431, PACS-IW-44, PACS-IW-441, PACS-IW-441TUVSW, PACS-IW-454, PACS-IW-476, PACSIW476UVTEST, PACS-IW-479, PACS-IW-486-UV, PACS-IW-486-UVN1, PACS-IW-487, PACS-IW-511, PACS-IW-518UV, PACS-IW-551UV, PACS-IW-551UVN1, PACS-IW-551UVN2, PACS-IW-556UV, PACS-IW-557, PACS-IW-56, PACS-IW-565, PACS-IW-574, PACS-IW-58, PACS-IW-581UV, PACS-IW-79, PACS-IW-93, PACS-IWT-565, PACSIWTEST, PACS-IWUV-1131, PACS-IWUV-481, PACS-IW-UVT370, PALMDALEM00558700, PALMDALEM01810788, PC1695SV01, PC1961SV02, PL0326RW01, PL1005RW01, PL1124RW01, PL1493RW02, PL1499RW03, PL1501RW03, PL1504RW02, PL2624RW01, PL2970RW01, PL2971RW01, PL2975RW02, PL3249RW02, PL3277RW01, PL3349PC01, PL3673RW01, PMRM14768587UVProxy, PRIME HEAL19050921, PRIME HEAL19050922, PRIME HEAL19508102, PSPC01815255, PX4900SV02, QTHBL02256595, QTHBL14767806UVSFVAL, QTHBL14767807UVSFSIM, QTHBL14767808UVSF1KO, QTHBL14767809UVSFBK, QTHBL14767810UVPROXY, QUENTIN01970717, RML01448365, RRA01814001, RU0003ID01, RU0120ID01, RU0472ID03, RU0968ID04, RU0994ID03, RU1011ID05, RU1107RW01, RU1107RW01, RU1112ID02, RU1516ID03, RU1516ID03, RU1544ID01, RU1646ID01, RU1717ID04, RU1781RW01, RU2580ID01, RU3052ID01, RU3453RW03, RU3794ID01, RU3998ID01, RU4255ID01, RU5388ID01, RU6164ID01, RU6968ID01, RU7175ID01, RU7468ID01, RU7519ID01, RU7808ID02, RU8002ID01, RU8366ID01, RU8945ID01, RU9216ID02, RU9226ID01, RU9255ID01, RU9327ID02, RU9546ID01, RU9595ID02, RU9697ID01, RU9940RW01, SA1339PP03, SA2402PP02, SFCS15961473, SFCS19667347, SMCO02039946PC, SUC00558667, TESTHANNIBALR02255613, TP0575UV02, TTU01973509, UHSD14767800,URSA20025013, UV1-154550926, VCM01819618, VCM02255583T, VCM02255586TSP, VISOU02288781, VISOU02345023, VMC02255587NSP, WGH00558334CTRL, WGH02372375BACK, WGH02372377PROX, X141385617, X314119802, ZA1058UV01, ZA2267PAC1, ZA2412PAC2, ZA2412PAC2, ZA2414PAC1, ZA2415PAC1, ZA2472PAC2, ZA2474UV01, ZA2541UV01 and ZA2551PAC1.
Center Classification Date20210922
Recall Initiation Date20210806
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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