Recall Z-0077-2017 ยท IYE Accelerator, Linear, Medical
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 condition
| Date | Oct 13, 2016 (initiated Sep 13, 2016) |
| Status | Terminated |
| 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 V |
| Quantity | 75 devices |
| Distribution | US Distribution and Internationally to 1 site in Canada, India and Morocco |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142560 | Varian Head Frame Varian Medical Systems, Inc., Dec 11, 2014 |