Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
FDA device recall Z-0163-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 3 units
- Distribution
- Nationwide Distribution: to the states of MO, VA, and WA.
- Date initiated
- 2010-09-17
- Date posted
- 2010-10-28
- Date terminated
- 2010-11-10
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTEND FRAME SYSTEM, MODEL 1009633 (K092083) | Elekta Instrument AB | 2009-09-22 |