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Class 2 Device Recall GammaMed Flexible Applicator Probe |
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Date Initiated by Firm |
August 05, 2008 |
Date Posted |
November 30, 2011 |
Recall Status1 |
Terminated 3 on December 07, 2011 |
Recall Number |
Z-0295-2012 |
Recall Event ID |
59856 |
510(K)Number |
K983436
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Product Classification |
System, applicator, radionuclide, remote-controlled - Product Code JAQ
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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 VA 22903-4584
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For Additional Information Contact |
Mark Kattmann 434-977-8495 Ext. 232
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Manufacturer Reason for Recall |
GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JAQ and Original Applicant = GAMMAMED USA
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