FDA-Device2018-08-01Class II
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
GE Healthcare, LLC
Hazard
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
Sold states
AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.
Affected count
58 (55 US, 3 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2018Don't want to check this manually?
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