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Terminated

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.

FDA Recall Z-0295-2012 · Posted 2011-11-30

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated2008-08-05
Date Terminated2011-12-07
Product Quantity653 parts

Reason for Recall

GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983436GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEMGammamed USA · 1998-10-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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