Recalls / —

—#94640

Product

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

FDA product code

IWB — System, Radiation Therapy, Radionuclide

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K092083

Affected lot / code info

Model #1009633 - Serial Numbers 6004, 6032 and 6078

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern

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

Timeline

Recall initiated

2010-09-17

Posted by FDA

2010-10-28

Terminated

2010-11-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #94640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.