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

Recall Z-0077-2017 — Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment t

U.S. FDA — Device Enforcement · United States · 2016-09-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0077-2017
Date of alert: 2016-09-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Varian Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue

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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