Z-0065-2014Class II

VARISOURCE Breast Template System for high-dose rate Brachytherapy. INSTRUCTIONS FOR USE Breast Bridge...

Name: Z-0065-2014 VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge...
Creator: Varian Medical Systems, Inc.
Published: 2013-08-09
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2013-08-09 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems, Inc. began a recall of VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer... on 2013-08-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0065-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-09
Posted: 2013-10-24
Terminated: 2014-04-10
Recalling firm: Varian Medical Systems, Inc.
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
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.
Quantity in commerce: 3 sets
Distribution: Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Product codes and lots: Lots #6078184-1, #6078184-2, #6078184-4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0065-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0065-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-24

Product code JAQ

K023220Class IIVarisource Breast Template SystemVarian Medical Systems / cleared 2002-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)