Recall Z-0330-2012
Varian Medical Systems, Inc. Oncology Systems · initiated October 6, 2011
Product
Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
Codes / lots: CODES: H630164 ,H630703 ,H630727 ,H630756 ,H630787 ,H630810 ,H630829 ,H630850 ,H630868 ,H630888 ,H630165 ,H630705 ,H630728 ,H630757 ,H630789 ,H630811 ,H630832 ,H630851 ,H630869 ,H630889 ,H630168 ,H630706 ,H630729 ,H630758 ,H630790 ,H630812 ,H630833 ,H630852 ,H630870 ,H630891 ,H630170 ,H630711 ,H630732 ,H630760 ,H630792 ,H630813 ,H630834 ,H630854 ,H630871 ,H630892 ,H630205 ,H630712 ,H630733 ,H630764 ,H630793 ,H630814 ,H630835 ,H630855 ,H630872 ,H630895 ,H630206 ,H630713 ,H630736 ,H630769 ,H630794 ,H630815 ,H630837 ,H630857 ,H630877 ,H630896 ,H630210 ,H630714 ,H630737 ,H630771 ,H630795 ,H630817 ,H630839 ,H630858 ,H630878 ,H630897 ,H630211 ,H630716 ,H630739 ,H630774 ,H630798 ,H630818 ,H630841 ,H630859 ,H630879 ,H630898 ,H630214 ,H630718 ,H630741 ,H630776 ,H630801 ,H630820 ,H630842 ,H630860 ,H630880 ,H630901 ,H630215 ,H630719 ,H630744 ,H630777 ,H630802 ,H630822 ,H630843 ,H630863 ,H630881 ,H630902 ,H630216 ,H630720 ,H630747 ,H630778 ,H630804 ,H630825 ,H630845 ,H630864 ,H630884 ,H630903 ,H630219 ,H630721 ,H630749 ,H630781 ,H630807 ,H630826 ,H630847 ,H630866 ,H630885 ,H630904 ,H630701 ,H630722 ,H630753 ,H630784 ,H630809 ,H630828 ,H630848 ,H630867 ,H630886
Reason for recall
The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
FDA-determined cause: Device Design
Action taken
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.
Details
- Recall number
- Z-0330-2012
- Initiated
- October 6, 2011
- Posted by FDA
- December 1, 2011
- Terminated
- October 22, 2012
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Distribution
- Worldwide Distribution--USA (nationwide).
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0329-2012 | Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm…The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the… | 10/06/2011Terminated |