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

Recall Z-0842-2018 — INFX-8000F Fluoroscopic X-Ray Systems

U.S. FDA — Device Enforcement · United States · 2017-12-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0842-2018
Date of alert
2017-12-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Toshiba American Medical Systems Inc
Product category
device
Product type
Devices
Reported risk: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
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.