Device 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.
Z-0077-2017
Product summary
- Event
- Event 75296
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 devices
- Official record key
device-enforcement:Z-0077-2017
Official wording
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
Code information: All Head Frame Posts and Post kits
Distribution pattern: US Distribution and Internationally to 1 site in Canada, India and Morocco
Derived failure modes
-
Unknown
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