—#89388

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.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K973441
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-01-07
Posted by FDA: 2010-05-14
Terminated: 2010-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.