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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Universal Viewer, Centricity Universal Viewer 6.0

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  Class 2 Device Recall Centricity Universal Viewer, Centricity Universal Viewer 6.0 see related information
Date Initiated by Firm August 06, 2021
Date Posted September 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-2503-2021
Recall Event ID 88526
510(K)Number K150420  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 462 (279 US; 183 OUS)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
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