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GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms
Recalled September 29, 2021 · FDA recall Z-2502-2021 · GE Healthcare
Hazard
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive · FDA Class II
Units
392 (219 US; 173 OUS) all products
Sold at
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.
Description
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Product
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →