Z-0163-2011

Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm...

Name: Z-0163-2011 Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm...
Creator: Elekta, Inc.
Published: 2010-09-17
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-09-17 / Terminated / root cause: packaging

FDA source

Elekta, Inc. began a recall of Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden on 2010-09-17. The reason FDA records is "The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0163-2011
Status: Terminated
Initiated: 2010-09-17
Posted: 2010-10-28
Terminated: 2010-11-10
Recalling firm: Elekta Limited
Product: Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
Product code: IWB System, Radiation Therapy, Radionuclide
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.
Root cause tag: packaging
FDA 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 in commerce: 3 units
Distribution: Nationwide Distribution: to the states of MO, VA, and WA.
Product codes and lots: Model #1009633 - Serial Numbers 6004, 6032 and 6078

Product code IWB

K092083Class IIExtend Frame System, Model 1009633Elekta Instrument AB / cleared 2009-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)