—#114302

Product

GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.

FDA product code: OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: part numbers: 5555000-5, 5555000-6

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-09-20
Posted by FDA: 2012-11-16
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.