Varian Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0065-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 9, 2013

Date Posted: October 30, 2013

Recall Number: Z-0065-2014

Event ID: 66121

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3 sets

Code Information:

Lots #6078184-1, #6078184-2, #6078184-4

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated