Recall Z-1501-2023 ยท LLZ System, Image Processing, Radiological
GE Healthcare
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 210
| 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 | 329 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150420 | Centricity Universal Viewer GE Healthcare, May 26, 2015 |