Product Wiki · Recalls · U.S. FDA — Device Enforcement

VARISOURCE Breast Template System for high-dose rate Brachytherapy — recall Z-0065-2014

U.S. FDA — Device Enforcement · United States · 2013-08-09 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0065-2014
Date of alert
2013-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Varian Medical Systems, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.