—#112107

Product

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved. Users are to contact 800-437-1171 in the US, if they have any questions or concerns.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) Distribution

Timeline

Recall initiated: 2012-07-10
Posted by FDA: 2012-09-13
Terminated: 2013-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.