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
Reported: October 30, 2013 Initiated: August 9, 2013 #Z-0065-2014
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.
Details
- Recalling Firm
- Varian Medical Systems, Inc.
- Units Affected
- 3 sets
- Distribution
- Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Varian Medical Systems, Inc.. Units affected: 3 sets.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2013. Severity: Moderate. Recall number: Z-0065-2014.
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