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

Recall Z-2642-2016 — Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

U.S. FDA — Device Enforcement · United States · 2016-04-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2642-2016
Date of alert
2016-04-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ziehm Imaging Inc
Product category
device
Product type
Devices
Reported risk: Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
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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