The FDA Enforcement Report for the week of March 6, 2013 lists the ongoing recall of the GE Brivo x-ray system.
The Class II Recall of the GE Healthcare Brivo XR385 DR-F/ x-ray system x-ray system, model number 5271997, involves only nine units installed in the US.
The company initiated the recall in August of 2012 because it became 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.
GE distributed the systems in various states, including New Mexico, Wyoming, Florida, Missouri, Massachusetts, and Michigan.
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