Recall Z-0163-2011 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
| Date | Oct 28, 2010 (initiated Sep 17, 2010) |
| Status | Terminated |
| Reason | The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy. |
| Root cause | Other |
| Action | Elekta issued an Important Notice: Urgent Field Safety Notice dated September 17, 2010 concerning Field Change Order 10000202003-A342 "Important Notice regarding recall of mouthpieces for EXTEND system, to all users of the EXTEND system for LGK Perfexion. the letter identified the issue and associated potential hazard, and requested the identification and return of all affected mouthpieces, and confirmation of receipt of the letter. Elekta will arrange return and replacement through local service representatives. Customers can contact Elekta concerning this recall at 770 300 9725. |
| Quantity | 3 units |
| Distribution | Nationwide Distribution: to the states of MO, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 Elekta Instrument AB, Sep 22, 2009 |