Recall Z-0065-2014— Varian Medical Systems, Inc.

Name: FDA recall Z-0065-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-09

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2013-08-09, terminated 2014-04-10. It names one FDA 510(k) clearance: K023220. 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. 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..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-09
Terminated: 2014-04-10
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K023220 — VARISOURCE BREAST TEMPLATE SYSTEMVarian Medical Systems·cleared 2002-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.