Recall Z-2992-2011 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc. Oncology Systems
GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: 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 bend
| Date | Aug 10, 2011 (initiated Jul 13, 2011) |
| Status | Terminated |
| Reason | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
| Root cause | Device Design |
| Action | Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory wi |
| Quantity | 601 - all sizes. |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, |
| 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 |