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U.S. Department of Health and Human Services

Class 2 Device Recall Varian Head Frame

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  Class 2 Device Recall Varian Head Frame see related information
Date Initiated by Firm September 13, 2016
Date Posted October 13, 2016
Recall Status1 Terminated 3 on February 24, 2017
Recall Number Z-0077-2017
Recall Event ID 75296
510(K)Number K142560  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information All Head Frame Posts and Post kits
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer 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
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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