FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc.: 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.
- Recall number
- Z-0077-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-09-13
- Posted
- 2016-10-13
- Terminated
- 2017-02-24
- Reason
- 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
- 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
- 75 devices
- Distribution
- US Distribution and Internationally to 1 site in Canada, India and Morocco
- Lot, serial or model codes
- All Head Frame Posts and Post kits
- 510(k) numbers
- ["K142560"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28