FDA recall Z-2523-2018

Product

Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2016-09-16

Report date

2018-08-01

Termination date

2018-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2018