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GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammog
Recalled November 14, 2018 · FDA recall Z-0374-2019 · GE Healthcare
Hazard
Synchronization failure · FDA Class II
Units
13
Sold at
CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
Description
Synchronization failure
Product
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation 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 →