Recall Z-0195-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
| Date | Aug 30, 2018 |
| Status | Terminated |
| Reason | Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. |
| Root cause | Component design/selection |
| Action | On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. 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 | 1 |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150420 | Centricity Universal Viewer GE Healthcare, May 26, 2015 |