Recall Z-0486-2007

Varian Medical Systems · initiated September 11, 2006

Terminated

Product

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

Codes / 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

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-0486-2007
Initiated
September 11, 2006
Posted by FDA
January 11, 2007
Terminated
May 18, 2007
Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Quantity
31 total units
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0487-2007 GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.Medical device for patient treatment does not meet electrical safety standards. 09/11/2006Terminated