Recall Z-3214-2024 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
| Date | Sep 24, 2024 (initiated Aug 5, 2024) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/05/2024 by letter delivered via traceable means. The notice explained the issue, potential risk to the patient, and requested the following: "You can continue to use your device if it has not reached the maximum number of Ckeys. In order to determine the remaining number of available Ckeys: " If GE HealthCare is remotely monitoring your Centricity PACS system as part of an existing service agreement, the number of available Ckeys is assessed routinely. If your device is close to maximum capacity, the GE |
| Quantity | 2138 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |