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Terminated

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

FDA Recall Z-0065-2014 · Posted 2013-10-24

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated2013-08-09
Date Terminated2014-04-10
Product Quantity3 sets

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.

Firm Action

Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023220VARISOURCE BREAST TEMPLATE SYSTEMVarian Medical Systems · 2002-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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