GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
FDA device recall Z-0199-2013 · posted 2012-11-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 364 total units installed in US
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-09-20
- Date posted
- 2012-11-16
- Date terminated
- 2013-12-05
- Location
- Waukesha, WI
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