Varian Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0077-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 13, 2016

Date Posted: October 19, 2016

Recall Number: Z-0077-2017

Event ID: 75296

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

Status: Terminated

Product Quantity: 75 devices

Code Information:

All Head Frame Posts and Post kits

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated