GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Reported: March 6, 2013 Initiated: August 3, 2012 #Z-0761-2013
Product Description
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Reason for Recall
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 9 units installed in US
- Distribution
- Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System. Recalled by GE Healthcare, LLC. Units affected: 9 units installed in US.
Why was this product recalled? ▼
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0761-2013.
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