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

Recall Z-2175-2018 — Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system

U.S. FDA — Device Enforcement · United States · 2018-03-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2175-2018
Date of alert
2018-03-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453567400741
Reported risk: The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
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.