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

Recall Z-0768-2016 — GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

U.S. FDA — Device Enforcement · United States · 2015-12-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0768-2016
Date of alert
2015-12-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
123456789
Reported risk: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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