FDA-Device2013-03-06Class II
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
GE Healthcare, LLC
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.
Sold states
Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
Affected count
9 units installed in US
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2013Don't want to check this manually?
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