—#88709

Product

Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063512
Affected lot / code info: Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.

Why it was recalled

Need to modify the closing speed of the shielding doors in the event of an emergency exit

Root cause (FDA determination)

Other

Action the firm took

A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.

Timeline

Recall initiated: 2007-07-02
Posted by FDA: 2010-03-17
Terminated: 2010-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.