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GE Healthcare, LLC recalls Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Recalled August 1, 2018 · FDA recall Z-2523-2018 · GE Healthcare
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. · FDA Class II
Units
58 (55 US, 3 OUS)
Sold at
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.
Description
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.
Product
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →