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

Optima XR220amx Mobile general purpose radiographic imaging of the… — recall Z-2255-2012

U.S. FDA — Device Enforcement · United States · 2012-07-10 · Class II

As described by U.S. FDA — Device Enforcement: Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2255-2012
Date of alert
2012-07-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution -- USA (nationwide) Distribution
Reported risk: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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