Recall Z-0486-2007 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
| Date | Jan 11, 2007 (initiated Sep 11, 2006) |
| Status | Terminated |
| Reason | Medical device for patient treatment does not meet electrical safety standards. |
| 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 | 31 total units |
| Distribution | Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil. |
| FDA record | Open on fda.gov |