Z-1604-2010

Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife...

Name: Z-1604-2010 Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife...
Creator: Elekta, Inc.
Published: 2008-01-07
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-01-07 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell... on 2008-01-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1604-2010
Status: Terminated
Initiated: 2008-01-07
Posted: 2010-05-14
Terminated: 2010-12-28
Recalling firm: Elekta Limited
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.
Product code: IWB System, Radiation Therapy, Radionuclide
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 root 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.
Product codes and lots: 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

Product code IWB

K973441Class IILeksell GammaplanPatterson Consulting Group, Inc. / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)