Z-0582-04

EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by...

Name: Z-0582-04 EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by...
Creator: Varian Medical Systems
Published: 2004-02-06
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2004-02-06 / Terminated / root cause: software

FDA source

Varian Medical Systems began a recall of EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304 on 2004-02-06. The reason FDA records is "Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy". 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-0582-04
Status: Terminated
Initiated: 2004-02-06
Posted: 2004-07-20
Terminated: 2004-09-21
Recalling firm: Varian Medical Systems, Inc.
Product: EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.
Quantity in commerce: 203
Distribution: Product was distributed to end users in the United States and internationally.
Product codes and lots: Serial numbers (Domestic units): 724 215 765 210 212 217 218 214 767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821 216 788 202 873 786 896 797 826 709 889 848

Product code JAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)