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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed Flexible Applicator Probe

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 Class 2 Recall
GammaMed Flexible Applicator Probe
see related information
Date Posted November 30, 2011
Recall Status1 Terminated on December 07, 2011
Recall Number Z-0295-2012
Recall Event ID 59856
Premarket Notification
510(K) Number
K983436 
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
Product GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
Code Information Part number GM11002560, Lots E01 to H14
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville, Virginia 22903-4584
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mark Kattmann
434-977-8495 Ext. 232
Manufacturer Reason
for Recall
GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.
Quantity in Commerce 653 parts
Distribution Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = GAMMAMED USA
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