Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed
FDA device recall Z-3055-2011 · posted 2011-08-22 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 1019 total
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-07-13
- Date posted
- 2011-08-22
- Date terminated
- 2012-06-20
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS (K033371) | Varian Medical Systems | 2003-12-24 |