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

Recall Z-0200-2013 — GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

U.S. FDA — Device Enforcement · United States · 2012-09-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0200-2013
Date of alert
2012-09-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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