Class 2 Device Recall LEKSELL GAMMAPLAN

• Date Initiated by Firm: January 07, 2008
• Date Posted: May 14, 2010
• Recall Status: Terminated on December 28, 2010
• Recall Number: Z-1604-2010
• Recall Event ID: 54890
• 510(K)Number: K973441
• Product Classification: system, radiation therapy, radionuclide - Product Code IWB
• Product: Leksell GammaPlan 8.0 image fusion; ; Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.
• Code Information: 2UA7361354, SG50425266, CZC75037DN, SG42820297, CZC707499P, SG34220707, CZC7044FLP, CZC7053FQD, CZC71228QT, CZC7354BN3, CZC740298, SG43520759, SG43720546, SG50825766, 2UA7291VKX, 2UA7291VJ3, US19378673, CZC354BN1, 0703150004, SG23320693, SG24820187, SG52720065, SG31620624, CZC70906S3, CZC70906SB, 2UA7361359, SG52720070, SG44925633, CZC70906S5, CZC7053FQ6, CZC706326M, 2UA736135C, 2UA7291VHT, SG34420200, SG32520836, 2UA7291VHY, 2UA7150VYH, SG43720660, CZC7481Q3R, SG50425271, SG50825764, US68115508, SG52720067, SG34620630, 2UA7251YHM, SG60320067, SG5272066, SG20620611, 2UA73317NW, SG41720274, SG41720317, SG31360678, SG40920412, SG31020317, SG33620363, SG24820212, CZC707499Q, CZC74024P9, SG42520530, CZC07031CRQ, CZC07031CRX, CZC70906S6, CZC70906S7, CZC7044FLN, SG50425273, SG50927332
• 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: The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2.
• FDA Determined Cause: Other
• Action: Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, do not hesitate to contact your Elekta support respresentative at
• Quantity in Commerce: 66 units
• Distribution: Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IL MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WA.
• 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 and Original Applicant = PATTERSON CONSULTING GROUP, INC.