Recall Z-2503-2021 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
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.
| Date | Sep 22, 2021 (initiated Aug 6, 2021) |
| Status | Open, Classified |
| Reason | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive |
| Root cause | 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 | 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 Afric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150420 | Centricity Universal Viewer GE Healthcare, May 26, 2015 |