VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template
FDA device recall Z-0065-2014 · posted 2013-10-24 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 3 sets
- Distribution
- Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
- Date initiated
- 2013-08-09
- Date posted
- 2013-10-24
- Date terminated
- 2014-04-10
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARISOURCE BREAST TEMPLATE SYSTEM (K023220) | Varian Medical Systems | 2002-10-25 |