Recall Z-3055-2011
Varian Medical Systems, Inc. Oncology Systems · initiated July 13, 2011
Product
Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
Codes / lots: Part number GM11002420; (part of Segmented Cyclinder Set, GM11004150). All lots.
Reason for recall
Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-3055-2011
- Initiated
- July 13, 2011
- Posted by FDA
- August 22, 2011
- Terminated
- June 20, 2012
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 1019 total
- Distribution
- Worldwide Distribution
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA