Recall Z-0012-2022 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
| Date | Oct 2, 2021 (initiated Aug 12, 2021) |
| Status | Terminated |
| Reason | A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). |
| Root cause | Other |
| Action | This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 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 | 49 |
| Distribution | AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182419 | Centricity Universal Viewer GE Healthcare, Dec 14, 2018 |