Recall Z-1502-2023 ยท LLZ System, Image Processing, Radiological
GE Healthcare
Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
| Date | May 2, 2023 (initiated Mar 28, 2023) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. |
| Root cause | Other |
| Action | GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction. |
| Quantity | 153 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082318 | CENTRICITY PACS IW Ge Healthcare Dynamic Imaging Solutions, Aug 25, 2008 |