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Terminated

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

FDA Recall Z-0163-2011 · Posted 2010-10-28

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2010-09-17
Date Terminated2010-11-10
Product Quantity3 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution: to the states of MO, VA, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092083EXTEND FRAME SYSTEM, MODEL 1009633Elekta Instrument AB · 2009-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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