Z-1398-06

GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number...

Name: Z-1398-06 GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number...
Creator: Varian Medical Systems
Published: 2006-05-01
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2006-05-01 / Terminated / root cause: software

FDA source

Varian Medical Systems began a recall of 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... on 2006-05-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1398-06
Status: Terminated
Initiated: 2006-05-01
Posted: 2006-08-10
Terminated: 2006-12-05
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: 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 tag: software
FDA 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 in commerce: 22 units
Distribution: Nationwide.
Product codes and lots: 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

Product code JAQ

K891131Class IIGammamed 12IMick Radio-Nuclear Instruments, Inc. / cleared 1989-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)