Recall Z-0487-2007
Varian Medical Systems · initiated September 11, 2006
Product
GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.
Codes / lots: H630202
Reason for recall
Medical device for patient treatment does not meet electrical safety standards.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0487-2007
- Initiated
- September 11, 2006
- Posted by FDA
- January 11, 2007
- Terminated
- May 18, 2007
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 1 unit
- Distribution
- Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
- Recalling firm
- Varian Medical Systems, Charlottesville, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0486-2007 | GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems…Medical device for patient treatment does not meet electrical safety standards. | 09/11/2006Terminated |