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

Recall Z-0404-2019 — Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R

U.S. FDA — Device Enforcement · United States · 2018-09-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0404-2019
Date of alert
2018-09-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Navigation, Inc.-Littleton
Product category
device
Product type
Devices
Reported risk: O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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