Z-0077-2017Class II

Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian...

Name: Z-0077-2017 Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian...
Creator: Varian Medical Systems, Inc.
Published: 2016-09-13
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2016-09-13 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of 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... on 2016-09-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0077-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-13
Posted: 2016-10-13
Terminated: 2017-02-24
Recalling firm: Varian Medical Systems, Inc.
Product: 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 code: IYE Accelerator, Linear, Medical
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
Root cause tag: design
FDA root cause: Device Design
Action: Varian Medical Systems sent an Urgent Medical Device Removal letter dated September 14, 2016, to all affected sites. Each site was also contacted by telephone to advice users of the issue and request of return of the head frame posts on September 14 and 15th. Calls enabled Varian to prioritize replacement parts for those with patients scheduled in the immediate future. Recommended User Actions: 1.CEASE USE of the Varian Head Frame Assembly and QUARANTINE the Varian Head Frame Assembly and components. 2.Collect, Clean, Disinfect all Head Frame Posts [PN1008016] if used previously. 3.Contact Varian 1.888.827.4265 for Return Material Authorization number, and return all Head Frame Posts in accordance with instructions provided with the enclosed Recall Return Material Form. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions, please call (650) 424-6833.
Quantity in commerce: 75 devices
Distribution: US Distribution and Internationally to 1 site in Canada, India and Morocco
Product codes and lots: All Head Frame Posts and Post kits

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0077-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code IYE

K142560Class IIVarian Head FrameVarian Medical Systems, Inc. / cleared 2014-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)