Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0143-2024 — Universal Viewer Workflow Manager, Image processing radiological system

U.S. FDA — Device Enforcement · United States · 2023-09-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0143-2024
Date of alert
2023-09-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278379610
Reported risk: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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