Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2523-2018 — Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

U.S. FDA — Device Enforcement · United States · 2016-09-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2523-2018
Date of alert
2016-09-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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