Recall Z-2996-2011
Varian Medical Systems, Inc. Oncology Systems · initiated July 13, 2011
Product
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 60 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
Codes / lots: Product number applicator Set: GM11006200;60 mm, 30 degree angle probe product number: GM11006160.
Reason for recall
Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
FDA-determined cause: Device Design
Action taken
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" 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 return all affected product to Varian Brachy Therapy by using the contact information provided in the letter. Replacement product will be provided free of charge to the customers. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
Details
- Recall number
- Z-2996-2011
- Initiated
- July 13, 2011
- Posted by FDA
- August 11, 2011
- Terminated
- June 20, 2012
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 437 - all sizes
- Distribution
- Worldwide Distribution.
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2995-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | 07/13/2011Terminated |
| Z-2997-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | 07/13/2011Terminated |
| Z-2998-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | 07/13/2011Terminated |
| Z-2999-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | 07/13/2011Terminated |
| Z-3000-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | 07/13/2011Terminated |