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Terminated

Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

FDA Recall Z-2523-2018 · Posted 2018-07-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2016-09-16
Date Terminated2018-07-26
Product Quantity58 (55 US, 3 OUS)

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.

Firm Action

An Important Electronic Product Radiation Warning letter was sent to consignees beginning 9/16/2016. The letter identified affected product, described the issue, and stated that GE will correct the devices without charge. Questions can be directed to 1-800-437-1171.

Root Cause

Component change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103448BRIVO XR385Ge Medical Systems, LLC · 2011-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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