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

Recall Z-1985-2021 — Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

U.S. FDA — Device Enforcement · United States · 2021-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1985-2021
Date of alert
2021-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838059542
Reported risk: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
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.