FDAFDA · Food and drugs·Recall number Z-0761-2013
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Published March 6, 2013 · Recall initiated: August 3, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
- Lot
- Model Number : 5271997
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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