Recall Z-0328-2012 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to faci
| Date | Dec 1, 2011 (initiated Sep 30, 2008) |
| Status | Terminated |
| Reason | Plastic needle tip could possibly crack or separate. |
| Root cause | Nonconforming Material/Component |
| Action | Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking. |
| Quantity | 1716 parts |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983436 | GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM Gammamed USA, Oct 29, 1998 |