FDA Medical Device Recalls (openFDA)
Varian Medical Systems: GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12i radionuclide applicator system.
- Recall number
- Z-1398-06
- Recalling firm
- Varian Medical Systems
- Product
- GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12i radionuclide applicator system.
- Status
- Terminated
- Initiated
- 2006-05-01
- Posted
- 2006-08-10
- Terminated
- 2006-12-05
- Reason
- Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
- Root cause
- Other
- Action
- The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only.
- Quantity
- 22 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- GammaMed ''12i'' serial numbers: GM00797 GM00795 GM00896 GM00852 GM00873 GM00708 GM0F278 GM00710 GM00848 GM00899 GM00820 GM00757 GM00821 GM00889 GM00727 GM00706 GM0710 GM00898 GM00743 GM00826 GM00784 GM00786
- 510(k) numbers
- ["K891131"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 3000206172
- Firm city
- Charlottesville
- Firm state
- VA
- 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