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

Recall Z-0448-2013 — GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is

U.S. FDA — Device Enforcement · United States · 2012-08-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0448-2013
Date of alert: 2012-08-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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