Recall Z-2502-2021 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
| 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 | 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 Afric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare, Nov 16, 2012 |