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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2503-2021 |
| Event ID | 88526 |
| Event 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. |
| Product Type | Devices |
| Distribution | AK, 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. |
| Quantity | 392 (219 US; 173 OUS) |
| Recall Reason | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive |
| Device Classification | 20210929 |
| Device Code Info | 2090255-001 (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 Date | 20210922 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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