FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc. Oncology Systems: 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.
- Recall number
- Z-3013-2011
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- 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.
- Status
- Terminated
- Initiated
- 2011-07-13
- Posted
- 2011-08-12
- Terminated
- 2012-06-20
- Reason
- Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Lots D01 to H14; Part number GM1102560
- 510(k) numbers
- ["K983436"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28