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
Product summary
- 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
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.