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
This recall has been terminated (originally issued October 24, 2013).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- August 9, 2013
- Posted
- October 24, 2013
- Terminated
- April 10, 2014
- Recall Number
- Z-0065-2014
- Quantity
- 3 sets
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Lot / Code Info
Lots #6078184-1, #6078184-2, #6078184-4
Root Cause
Nonconforming Material/Component
Action Taken
Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.
More recalls by Varian Medical Systems, Inc.
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical syste...
Jun 26, 2015
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)
Product...
May 15, 2013