Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 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.
FDA Recall Z-3000-2011 · Posted 2011-08-11
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2011-07-13
Date Terminated2012-06-20
Product Quantity437 - all sizes
Reason for Recall
Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
Firm Action
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
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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