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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed Flexible Applicator

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  Class 2 Device Recall GammaMed Flexible Applicator see related information
Date Initiated by Firm July 13, 2011
Date Posted August 12, 2011
Recall Status1 Terminated 3 on June 20, 2012
Recall Number Z-3013-2011
Recall Event ID 59388
510(K)Number K983436  
Product Classification Radionuclide System Applicator, Remote-Controlled - Product Code JAQ
Product GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF.

Varian Medical Systems, Palo Alto, CA.
Mfg by Varian Medical Systems, Haan GmbH.

Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.
Code Information Lots D01 to H14; Part number GM1102560
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		 Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
FDA Determined
Cause 2		 Process control
Action Varian Medical Systems, Inc. sent out Customer Technical bulletins in August 2008 and Urgent Medical Device Correction/Urgent Field Safety Notices on July 13, 2011 to all affected customers. The letter included description of device and problem. The current notice supplements and modifies previous instructions and ask that they stop using any flexible applicator probes in inventory. They are to be returned to Varian Brachy Therapy for replacement. Letter go on to list possible scenarios if the length deviation is not detected and advised all personnel working in the radiotherapy department should be notified of the recall. For additional information contact (800) 360-7909.
Quantity in Commerce 1343
Distribution Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.
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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