Varian Medical Systems, Inc. recalls Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Fram…

Recall date

September 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0077-2017

FDA classification

Class II

Brand / firm

Varian Medical Systems, Inc.

Sold / distributed

US Distribution and Internationally to 1 site in Canada, India and Morocco

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.