Class 2 Device Recall Leksell Gamma Knife.

• Date Initiated by Firm: October 01, 2007
• Date Posted: April 13, 2010
• Recall Status: Terminated on December 28, 2010
• Recall Number: Z-1236-2010
• Recall Event ID: 55001
• 510(K)Number: K984328
• Product Classification: Gamma Knife (Radionuclide radiation therapy system) - Product Code IWB
• Product: Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
• Code Information: LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 30092-3011
• For Additional Information Contact: Thomas Valentine; 770-670-2548
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 5 units
• Distribution: United States (CA, TN, TX and WA) and Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IWB