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.
This recall has been terminated (originally issued August 11, 2011).
- Recall Initiated
- July 13, 2011
- Posted
- August 11, 2011
- Terminated
- June 20, 2012
- Recall Number
- Z-2996-2011
- Quantity
- 437 - all sizes
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
Distribution
Worldwide Distribution.
Lot / Code Info
Product number applicator Set: GM11006200;60 mm, 30 degree angle probe product number: GM11006160.
Root 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.