Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Reported: September 29, 2021 Initiated: August 6, 2021 #Z-2502-2021
Product Description
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Reason for Recall
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 392 (219 US; 173 OUS) all products
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.. Recalled by GE Healthcare, LLC. Units affected: 392 (219 US; 173 OUS) all products.
Why was this product recalled? ▼
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2502-2021.
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