Recall Z-0329-2012 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc. Oncology Systems
Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-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 r
| Date | Dec 1, 2011 (initiated Oct 6, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Distribution | Worldwide Distribution--USA (nationwide). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891131 | GAMMAMED 12I Mick Radio-Nuclear Instruments, Inc., Aug 7, 1989 |