GE Healthcare, LLC recalls Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

Recall date

September 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2523-2018

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brivo XR385, model 5215463, Digital Diagnostic Radiographic System