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Terminated

GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

FDA Recall Z-0197-2013 · Posted 2012-11-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeOXO
Date Initiated2012-09-20
Date Terminated2013-12-05
Product Quantity364 total units installed in US

Reason for Recall

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.

Firm Action

GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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