Centricity recallZ-2503-2021 · GE Healthcare, LLC · initiated Aug 6, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2503-2021
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2021
- Posted by the FDA
- Sep 22, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 462 (279 US; 183 OUS)
- Product code
- LLZ
- FDA submissions
- K150420
- 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.
Product 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. 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.
Code information (models, lots, serial numbers)
Show the full code information (8k characters)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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