Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper
FDA device recall Z-2998-2011 · posted 2011-08-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 437 - all sizes
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-07-13
- Date posted
- 2011-08-11
- 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.
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