Recall Z-0761-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-08-03, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System. Reason: 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-03
- Terminated
- 2013-12-05
- Firm location
- Waukesha, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.