Z-0486-2007

GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA

Name: Z-0486-2007 GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
Creator: Varian Medical Systems
Published: 2006-09-11
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2006-09-11 / Terminated

FDA source

Varian Medical Systems began a recall of GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA on 2006-09-11. The reason FDA records is "Medical device for patient treatment does not meet electrical safety standards". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0486-2007
Status: Terminated
Initiated: 2006-09-11
Posted: 2007-01-11
Terminated: 2007-05-18
Recalling firm: Varian Medical Systems, Inc.
Product: GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Medical device for patient treatment does not meet electrical safety standards.
FDA root cause: Other
Action: The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.
Quantity in commerce: 31 total units
Distribution: Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
Product codes and lots: H630701 H630703 H630704 H630705 H630706 H630708 H630710 H630711 H630712 H630713 H630714 H630715 H630716 H630718 H630719 H630720 H630721 H630722 H630723 H630724 H630725 H630727 H630728 H630729 7H63030 H630732 H630733 H630735 H630736 H630737 H630739

Product code JAQ

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)