—#89656

Product

Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K984328
Affected lot / code info: LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.

Why it was recalled

After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.

Root cause (FDA determination)

Other

Action the firm took

Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.

Recalling firm

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

Distribution

Distribution pattern: United States (CA, TN, TX and WA) and Taiwan.

Timeline

Recall initiated: 2007-10-01
Posted by FDA: 2010-04-13
Terminated: 2010-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89656. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.