Product Safety Recalls

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GE Healthcare, LLC Recall 88526

Description: Centricity PACS-IW with Universal Viewer - 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-2502-2021
Event ID88526
Event DescriptionCentricity PACS-IW with Universal Viewer - 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) all products
Recall ReasonImage acquisition failures and synchronization failure with the Centricity Enterprise Archive
Device Classification20210929
Device Code Info2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1
Center Classification Date20210922
Recall Initiation Date20210806
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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