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

Recall Z-0973-2014 — Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and ob

U.S. FDA — Device Enforcement · United States · 2013-07-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0973-2014
Date of alert: 2013-07-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation, Inc.
Product category: device
Product type: Devices

Reported risk: Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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