Recall Z-0921-05 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
| Date | Jun 22, 2005 (initiated Apr 14, 2005) |
| Status | Terminated |
| Reason | A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury. |
| Root cause | Other |
| Action | The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website. |
| Quantity | 33 devices in domestic distribution |
| Distribution | Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally. |
| 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 |