Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
This recall has been terminated (originally issued October 28, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- September 17, 2010
- Posted
- October 28, 2010
- Terminated
- November 10, 2010
- Recall Number
- Z-0163-2011
- Quantity
- 3 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.
Distribution
Nationwide Distribution: to the states of MO, VA, and WA.
Lot / Code Info
Model #1009633 - Serial Numbers 6004, 6032 and 6078
Root Cause
Other
Action Taken
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.