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) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Recommended Action

Per FDA guidance

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.