FDAClass IIOctober 19, 2016

Varian Head Frame recall

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…

Why was Varian Head Frame recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Head Frame Posts and Post kits

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…
Recalling firm
Varian Medical Systems, Inc.
Quantity
75 devices
Distribution
US Distribution and Internationally to 1 site in Canada, India and Morocco
Recall date
October 19, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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