GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Reported: November 28, 2012 Initiated: September 20, 2012 #Z-0200-2013
Product Description
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 364 total units installed in US
- Distribution
- Nationwide Distribution
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.. Recalled by GE Healthcare, LLC. Units affected: 364 total units installed in US.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0200-2013.
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