Home / Recalls / Varian Medical Systems, Inc. / Z-0077-2017

Z-0077-2017 Class II Terminated

Recalled by Varian Medical Systems, Inc. — Palo Alto, CA

Recall Details

Product Type
Devices
Report Date
October 19, 2016
Initiation Date
September 13, 2016
Termination Date
February 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75 devices

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

All Head Frame Posts and Post kits

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