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.
Enforcement
- Recall Number
- Z-0077-2017
- Event ID
- 75296
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Varian Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 19, 2016
- Initiation Date
- September 13, 2016
- Classification Date
- October 13, 2016
- Termination Date
- February 24, 2017
- Address
- 911 Hansen Way, N/A, Palo Alto, CA, 94304-1028, United States
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.
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
All Head Frame Posts and Post kits
US Distribution and Internationally to 1 site in Canada, India and Morocco
75 devices