Skip to content
Recall Observatory FDA recall evidence

Device product

VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA

Z-0065-2014

August 09, 2013

Class II

Product summary

Firm
Varian Medical Systems, Inc.
Event
Event 66121
Status
Terminated
Classification
Class II
Quantity
3 sets
Official record key
device-enforcement:Z-0065-2014

Official wording

Reason: The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

Code information: Lots #6078184-1, #6078184-2, #6078184-4

Distribution pattern: Worldwide distribution: US (nationwide) distribution in CA and in the country of India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.