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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Fletcherstyle Applicator Set Defined Geometry CT Compatible

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  Class 2 Device Recall Titanium Fletcherstyle Applicator Set Defined Geometry CT Compatible see related information
Date Initiated by Firm July 13, 2011
Date Posted August 11, 2011
Recall Status1 Terminated 3 on June 20, 2012
Recall Number Z-2995-2011
Recall Event ID 59404
510(K)Number K983436  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 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.
Code Information Product number applicator Set: GM11006200;40 mm, 30 degree angle probe product number: GM11006140.
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 437 - all sizes
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = GAMMAMED USA
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