GE Healthcare, LLC Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
PMIO20084199, PACS-IW-231, CITRUSVAL20884363, CITRUSVAL20884364, CITRUSVAL20884365, PACS-IW-155, PRIMEHEAL02315681, PRIMEHEAL20501355, PARKVIEWC21200827 (840682103800), PARKVIEWC21200830 (840682103800), PACS-IWUVN2-441, QUEEN19630914, QUEEN19630915, QUEEN19630916T, QUEEN20553950, 203268UVSW, DELAWAREC01589220, PACS-IW-462UV, PACS-IW-462UVN1, PACS-IW-126, PACS-IW-1062, OFMC01819402, OFMC20791988, HGS01766912, HGS20584004 (840682103800), GA001PACTRL01, TRGI02180958, DRY01810490, DRY19670358, PACS-IW-101, RML20502096, PACS-IWUV-239, PACS-IW-00813, PHS01374810, 01722652SEAS, 02031921SEASN1, MARYLANDF17985489, MYRTLEHIL17713895, MYRTLEHIL01444483, MYRTLEHIL17713895, VT01766830, VT01977629, PACS-IW-2637, SRMC01982629, PACS-IWUV-568, 1-142022244, PACS-IWUV-1131, OGAA02373799NOD1, ALLG00558571 (840682103800), EXC02189547, EXC01584099, PACS-IW-574, PRIME HEAL19508102, PRIME HEAL19050922, PRIME HEAL19050921, PACS-IW-219, ANCL00558570, ANCL02157634, NSW01452088, NSW20080545, MARYLANDF17985489, PACS-IW-518UV (840682103800), MTGD02393053, MTGD00558454, PACS-IW-44, QUENTIN01970717, LAKESIDEM02256808, BMC12P00558644P1, BMC12T02267839, BMC12N01271417N1, PACS-IW-58, SMCO02039946PC (840682103800), BWH01301357, PACS-IW-349, PACS-IW-255, 1-357059471, CAROCOMMU02205222, CAROCOMMU01459013, CSPA01291589 (840682103800), CSPA02097167 (840682103800), PACS-IW-79, PACS-IW-93, 1-276423210, MFCI01448329, LSFH02032334, CORONAREG01300927, 951737IWUWWN1, CORONAREG02288447, 1-382753509, CITRUSVAL19618406, MGMC02288391, MGMC02398531, 1-473998727, BARRETTHO00558704, BARRETTHO17737529, FORTDUNCA01298556 (840682103800), FORTDUNCA02395799 (840682103800), 1-283597082, TTU01973509, AVHL02396030, PACS-IW-511, PACSIWTEST, PACS-IW-386UV (840682103800), PACS-IW-486-UV (840682103800), PACS-IW-486-UVN1 (840682103800), PACS-IW-390 (840682103800), PACS-IW-202TEST, PACS-IW-202, HZC14961014, AVHL02396026, AVHL02396027, AVHL02396028, AVHL02396029, PACS-IW-419, PMRM14768587UVProxy, HANNIBALR02179353 (840682103800), TESTHANNIBALR02255613 (840682103800), HANN16174584UVProxy (840682103800), PACS-IW-189 (840682103800), HARTSDALE14768195 (840682103800), HOA01451973 (840682103800), RML01448365 (840682103800), ICA01367198 (840682103800), ICA14776604 (840682103800), JKS01452133 (840682103800), JKS14776447UVSFNode (840682103800), JKS14776448UVProxy (840682103800), JKS14776449UVTest (840682103800), PACS-IW-181, GTEC01477448, GTEC01477447, GTEC15993728UVProxy3, 1-592001096 (840682103800), UHSD14767800 (840682103800), PACS-IW-551UVN1 (840682103800), PACS-IW-551UVN2 (840682103800), UV1-154550926, DHOL19603374, DHOL19603375, PACS-IW-551UV (840682103800), PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, SFCS19667347, SFCS15961473, SFCS15961473, MHOG01806096, PACS-IW-166, PACS-IW-166T, MCT02277843, MCT02278145, PACS-IW-565, PACS-IWT-565, WGH00558334CTRL, WGH02372377PROX, WGH02372375BACK, 1-464783615, PACS-IW-389, BVH00558643, PACS-IW-348UV (840682103800), NRVM19609993UVT (840682103800), NRVM19611189UVPROXY (840682103800), PACS-IW-441, PACS-IW-441TUVSW, PACS-IW-402, PACS-IW-318, MINNETOHE, PACS-IW-253, PACS-IW-581UV, PACS-IW-370, PACS-IW-UVT370, VISOU02345023, VISOU02288781, 1-218291079, 1-103108035, MFHO14767332, PALMDALEM00558700, PALMDALEM01810788, PACS-IW-454, PACS-IW-406, 20101378UBSW, ILCC01373579 (840682103800), ILCC14580319 (840682103800), 516473UVSW (840682103800), JOHNTMA19732280T (840682103800), 1-182669905, NCDC20279342, CENTERFOR01627896, CENTERFOR16023960UVProxy, PACS-IW-176, PACS-IW-176UVTEST, PACS-IW-405, PACS-IW-336, NASONHOSP14898835, RRA01814001, MYRTLEHIL01444483, PSPC01815255, 1-283596904, HOOO20091140, GZMG02182469CNTRLR (840682103800), GZMG02287985 (840682103800), GZMG02288300 (840682103800), PACS-IW-556UV, URSA20025013, PACS-IW-431, 1-598891598, PACS-IW-230, INTERCOAST17594527UVProxy, MDHC16204735UVProxy, 201392UVSW, 505368UVBSW (840682103800), NNAR14767799 (840682103800), PACS-IW-479, PACS-IW-557 (840682103800), URS20583582 (840682103800), PACS-IWUV-481, PACS-IW-476, PACSIW476UVTEST, GGMC02349137, 1-486091448, 1-486091475, 1-750710672, SUC00558667, 1-802428413, 954688UVBSW100, PACS-IW-1511, KDH217192544, ACP00558109, PACS-IW-31Test1, PACS-IW-31Test, ACP01613226, 1-219095008, OKOS14767330, 918277CVUWBSW, CCA20759776SF, PACS-IW-487, QTHBL14767810UVPROXY, QTHBL14767809UVSFBK, QTHBL14767808UVSF1KO, QTHBL14767807UVSFSIM, QTHBL14767806UVSFVAL, QTHBL02256595, VCM02255583T, VCM01819618, VCM02255586TSP, VMC02255587NSP, BOJC00558520, PACS-IW-56, PACS-IW-225, 1-375705893, DDNI14776603, PACS-IW-129, DISSFHW01, 1-644600677, PACS-IW-154UV, FLMC14777071, NEWYORK01291738, OANT02035061, PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, VBHCP20497227, PACS-IW-2635, PREMI02182462, PREMI02182462, NORTHWEST01804127, HCIT4271649UW, AH4325SV01, AH5291PC02, AP6264PC01, AP6469PC01, AH0116SV03, AH0106SV03, HCD4440494UV, HCIT4258559UV, HCIT7109403UV, HCIT4244609UV, HCIT4708563UV, HCIT4470563UV-CTRL, HCIT4261024UVCTRL, HCIT7113573UV, 519264PACSAW1 (840682103800), 416813UV (840682103800), 416813TESTRPACSUV (840682103800), HCIT4266470UW, HCIT4238540UV, HCIT4486723UV, E4167658, X314119802, X141385617, A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271, A9190177, M41980107, M4487535, M44997011, HC0399UV01, CC4105PC02, PC1695SV01, 786787SV02, HBON01SV02, HC4105PC01, 509940UV01, HC0529PC01, HC0529PC01, 233638UV01, HC0245PC02, 600791PC02, 427990UV01, PC1961SV02, 531344PC01, 434487SV03, PX4900SV02, HC0565PC03, TP0575UV02, GH1077UV01, 083055820116113, 083055824999515, 083055861021012, 83055862088813, 083055800046112, 81111DBS01, IL1469IT05, IL1469IT16, A5992711, A5412010, A6197102, KW0000PP02, HCIT4175024UV, AMS3963, BON0164, ECT0265, HCIT4192962UV, HCIT4264206UW, PL3673RW01, PL1493RW02, PL2970RW01, PL1124RW01, PL1499RW03, PL3349PC01, PL1501RW03, PL2624RW01, PL3249RW02, PL3277RW01, PL1005RW01, 600062UV, PL3362RW01, PL0326RW01, PL2975RW02, PL1504RW02, PL2971RW01, RU9255ID01, RU6968ID01, RU8945ID01, RU7519ID01, RU1781RW01, RU2580ID01, RU4255ID01, RU0003ID01, RU0472ID03, RU9595ID02, RU9327ID02, RU1011ID05, RU8366ID01, RU7808ID02, RU1516ID03, RU1646ID01, RU1112ID02, 01977813, 01980259, RU3052ID01, RU1107RW01, RU1107RW01, RU7175ID01, RU1717ID04, RU9216ID02, RU3453RW03, 600101RW02, RU8002ID01, RU1544ID01, RU1516ID03, RU9940RW01, RU5388ID01, RU0994ID03, RU3794ID01, RU9226ID01, RU9697ID01, 1509505, RU0968ID04, RU0120ID01, RU6164ID01, RU9546ID01, RU7468ID01, RU3998ID01, 600105ID03, SA2402PP02, SA2110PP05, SA1339PP03, ZA2541UV01, ZA2414PAC1, ZA2415PAC1, ZA2474UV01, ZA2267PAC1, ZA1058UV01, ZA2551PAC1, ZA1058UV01, ZA2412PAC2, ZA2472PAC2, ZA000010, ZA2412PAC2, MPX35219, DP760316, FP502804, 802030PC01, 228493WS01, 124774CS01, 482896SV03, 06051PAC04, HCIT4133734PACS, HCIT4148106PEE, UDI-DI: 840682103800, System ID: NYHOSPI16204605, NYHOSPI16204606, NYHOSPI16204607, NYHOSPI16204608, NYHOSPI16204609, NYHOSPI16204612, UDI-DI: 840682103800, UDI-DI: 840682103800, System ID: DDOC02339896.
Products Sold
1. Model Number: 2090255-001 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1) System ID (UDI-DI if applicable): PMIO14194768, PMIO20084199, PACS-IW-231, CITRUSVAL20884363, CITRUSVAL20884364, CITRUSVAL20884365, PACS-IW-155, PRIMEHEAL02315681, PRIMEHEAL20501355, PARKVIEWC21200827 (840682103800), PARKVIEWC21200830 (840682103800), PACS-IWUVN2-441, QUEEN19630914, QUEEN19630915, QUEEN19630916T, QUEEN20553950, 203268UVSW, DELAWAREC01589220, PACS-IW-462UV, PACS-IW-462UVN1, PACS-IW-126, PACS-IW-1062, OFMC01819402, OFMC20791988, HGS01766912, HGS20584004 (840682103800), GA001PACTRL01, TRGI02180958, DRY01810490, DRY19670358, PACS-IW-101, RML20502096, PACS-IWUV-239, PACS-IW-00813, PHS01374810, 01722652SEAS, 02031921SEASN1, MARYLANDF17985489, MYRTLEHIL17713895, MYRTLEHIL01444483, MYRTLEHIL17713895, VT01766830, VT01977629, PACS-IW-2637, SRMC01982629, PACS-IWUV-568, 1-142022244, PACS-IWUV-1131, OGAA02373799NOD1, ALLG00558571 (840682103800), EXC02189547, EXC01584099, PACS-IW-574, PRIME HEAL19508102, PRIME HEAL19050922, PRIME HEAL19050921, PACS-IW-219, ANCL00558570, ANCL02157634, NSW01452088, NSW20080545, MARYLANDF17985489, PACS-IW-518UV (840682103800), MTGD02393053, MTGD00558454, PACS-IW-44, QUENTIN01970717, LAKESIDEM02256808, BMC12P00558644P1, BMC12T02267839, BMC12N01271417N1, PACS-IW-58, SMCO02039946PC (840682103800), BWH01301357, PACS-IW-349, PACS-IW-255, 1-357059471, CAROCOMMU02205222, CAROCOMMU01459013, CSPA01291589 (840682103800), CSPA02097167 (840682103800), PACS-IW-79, PACS-IW-93, 1-276423210, MFCI01448329, LSFH02032334, CORONAREG01300927, 951737IWUWWN1, CORONAREG02288447, 1-382753509, CITRUSVAL19618406, MGMC02288391, MGMC02398531, 1-473998727, BARRETTHO00558704, BARRETTHO17737529, FORTDUNCA01298556 (840682103800), FORTDUNCA02395799 (840682103800), 1-283597082, TTU01973509, AVHL02396030, PACS-IW-511, PACSIWTEST, PACS-IW-386UV (840682103800), PACS-IW-486-UV (840682103800), PACS-IW-486-UVN1 (840682103800), PACS-IW-390 (840682103800), PACS-IW-202TEST, PACS-IW-202, HZC14961014, AVHL02396026, AVHL02396027, AVHL02396028, AVHL02396029, PACS-IW-419, PMRM14768587UVProxy, HANNIBALR02179353 (840682103800), TESTHANNIBALR02255613 (840682103800), HANN16174584UVProxy (840682103800), PACS-IW-189 (840682103800), HARTSDALE14768195 (840682103800), HOA01451973 (840682103800), RML01448365 (840682103800), ICA01367198 (840682103800), ICA14776604 (840682103800), JKS01452133 (840682103800), JKS14776447UVSFNode (840682103800), JKS14776448UVProxy (840682103800), JKS14776449UVTest (840682103800), PACS-IW-181, GTEC01477448, GTEC01477447, GTEC15993728UVProxy3, 1-592001096 (840682103800), UHSD14767800 (840682103800), PACS-IW-551UVN1 (840682103800), PACS-IW-551UVN2 (840682103800), UV1-154550926, DHOL19603374, DHOL19603375, PACS-IW-551UV (840682103800), PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, SFCS19667347, SFCS15961473, SFCS15961473, MHOG01806096, PACS-IW-166, PACS-IW-166T, MCT02277843, MCT02278145, PACS-IW-565, PACS-IWT-565, WGH00558334CTRL, WGH02372377PROX, WGH02372375BACK, 1-464783615, PACS-IW-389, BVH00558643, PACS-IW-348UV (840682103800), NRVM19609993UVT (840682103800), NRVM19611189UVPROXY (840682103800), PACS-IW-441, PACS-IW-441TUVSW, PACS-IW-402, PACS-IW-318, MINNETOHE, PACS-IW-253, PACS-IW-581UV, PACS-IW-370, PACS-IW-UVT370, VISOU02345023, VISOU02288781, 1-218291079, 1-103108035, MFHO14767332, PALMDALEM00558700, PALMDALEM01810788, PACS-IW-454, PACS-IW-406, 20101378UBSW, ILCC01373579 (840682103800), ILCC14580319 (840682103800), 516473UVSW (840682103800), JOHNTMA19732280T (840682103800), 1-182669905, NCDC20279342, CENTERFOR01627896, CENTERFOR16023960UVProxy, PACS-IW-176, PACS-IW-176UVTEST, PACS-IW-405, PACS-IW-336, NASONHOSP14898835, RRA01814001, MYRTLEHIL01444483, PSPC01815255, 1-283596904, HOOO20091140, GZMG02182469CNTRLR (840682103800), GZMG02287985 (840682103800), GZMG02288300 (840682103800), PACS-IW-556UV, URSA20025013, PACS-IW-431, 1-598891598, PACS-IW-230, INTERCOAST17594527UVProxy, MDHC16204735UVProxy, 201392UVSW, 505368UVBSW (840682103800), NNAR14767799 (840682103800), PACS-IW-479, PACS-IW-557 (840682103800), URS20583582 (840682103800), PACS-IWUV-481, PACS-IW-476, PACSIW476UVTEST, GGMC02349137, 1-486091448, 1-486091475, 1-750710672, SUC00558667, 1-802428413, 954688UVBSW100, PACS-IW-1511, KDH217192544, ACP00558109, PACS-IW-31Test1, PACS-IW-31Test, ACP01613226, 1-219095008, OKOS14767330, 918277CVUWBSW, CCA20759776SF, PACS-IW-487, QTHBL14767810UVPROXY, QTHBL14767809UVSFBK, QTHBL14767808UVSF1KO, QTHBL14767807UVSFSIM, QTHBL14767806UVSFVAL, QTHBL02256595, VCM02255583T, VCM01819618, VCM02255586TSP, VMC02255587NSP, BOJC00558520, PACS-IW-56, PACS-IW-225, 1-375705893, DDNI14776603, PACS-IW-129, DISSFHW01, 1-644600677, PACS-IW-154UV, FLMC14777071, NEWYORK01291738, OANT02035061, PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, VBHCP20497227, PACS-IW-2635, PREMI02182462, PREMI02182462, NORTHWEST01804127, HCIT4271649UW, AH4325SV01, AH5291PC02, AP6264PC01, AP6469PC01, AH0116SV03, AH0106SV03, HCD4440494UV, HCIT4258559UV, HCIT7109403UV, HCIT4244609UV, HCIT4708563UV, HCIT4470563UV-CTRL, HCIT4261024UVCTRL, HCIT7113573UV, 519264PACSAW1 (840682103800), 416813UV (840682103800), 416813TESTRPACSUV (840682103800), HCIT4266470UW, HCIT4238540UV, HCIT4486723UV, E4167658, X314119802, X141385617, A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271, A9190177, M41980107, M4487535, M44997011, HC0399UV01, CC4105PC02, PC1695SV01, 786787SV02, HBON01SV02, HC4105PC01, 509940UV01, HC0529PC01, HC0529PC01, 233638UV01, HC0245PC02, 600791PC02, 427990UV01, PC1961SV02, 531344PC01, 434487SV03, PX4900SV02, HC0565PC03, TP0575UV02, GH1077UV01, 083055820116113, 083055824999515, 083055861021012, 83055862088813, 083055800046112, 81111DBS01, IL1469IT05, IL1469IT16, A5992711, A5412010, A6197102, KW0000PP02, HCIT4175024UV, AMS3963, BON0164, ECT0265, HCIT4192962UV, HCIT4264206UW, PL3673RW01, PL1493RW02, PL2970RW01, PL1124RW01, PL1499RW03, PL3349PC01, PL1501RW03, PL2624RW01, PL3249RW02, PL3277RW01, PL1005RW01, 600062UV, PL3362RW01, PL0326RW01, PL2975RW02, PL1504RW02, PL2971RW01, RU9255ID01, RU6968ID01, RU8945ID01, RU7519ID01, RU1781RW01, RU2580ID01, RU4255ID01, RU0003ID01, RU0472ID03, RU9595ID02, RU9327ID02, RU1011ID05, RU8366ID01, RU7808ID02, RU1516ID03, RU1646ID01, RU1112ID02, 01977813, 01980259, RU3052ID01, RU1107RW01, RU1107RW01, RU7175ID01, RU1717ID04, RU9216ID02, RU3453RW03, 600101RW02, RU8002ID01, RU1544ID01, RU1516ID03, RU9940RW01, RU5388ID01, RU0994ID03, RU3794ID01, RU9226ID01, RU9697ID01, 1509505, RU0968ID04, RU0120ID01, RU6164ID01, RU9546ID01, RU7468ID01, RU3998ID01, 600105ID03, SA2402PP02, SA2110PP05, SA1339PP03, ZA2541UV01, ZA2414PAC1, ZA2415PAC1, ZA2474UV01, ZA2267PAC1, ZA1058UV01, ZA2551PAC1, ZA1058UV01, ZA2412PAC2, ZA2472PAC2, ZA000010, ZA2412PAC2, MPX35219, DP760316, FP502804, 802030PC01, 228493WS01, 124774CS01, 482896SV03, 06051PAC04, HCIT4133734PACS, HCIT4148106PEE, Others Tracked under Service Cloud product ID. 2. Model Number: 2088026-723 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1); UDI-DI: 840682103800; System ID: NYHOSPI16204605, NYHOSPI16204606, NYHOSPI16204607, NYHOSPI16204608, NYHOSPI16204609, NYHOSPI16204612, NYHOSPI16204613. 3. Model Number: 2102676-001 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1); UDI-DI: 840682103800; System ID: PACS-IW-119. 4. Model Number: 2104867-044 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1); UDI-DI: 840682103800; System ID: DDOC02339896.
GE Healthcare, LLC is recalling Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images due to Image acquisition failures and synchronization failure with the Centricity Enterprise Archive. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Recommended Action
Per FDA guidance
This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, CA, CO, DE, FL, GA, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, WA, WV, WI, WY
Page updated: Jan 10, 2026