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 12it radionuclide applicator system.
- Recall number
- Z-1399-06
- 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 12it 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
- 13 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- GammaMed ''12it'' serial numbers: GM00213 GM00218 GM00219TB GM00215 GM00202 GM00216 GM00217 GM00212 GM00219TA GM00219 GM00210 GM00214 GM0213
- 510(k) numbers
- ["K912555"]
- 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