Z-1231-2010

Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated...

Name: Z-1231-2010 Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated...
Creator: Elekta, Inc.
Published: 2007-05-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2007-05-30 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of... on 2007-05-30. The reason FDA records is "There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1231-2010
Status: Terminated
Initiated: 2007-05-30
Posted: 2010-04-05
Terminated: 2010-12-28
Recalling firm: Elekta Limited
Product: Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.
Root cause tag: software
FDA root cause: Software design
Action: Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.
Quantity in commerce: 18 units
Distribution: Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
Product codes and lots: Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.

Product code IWB

K063512Class IILeksell Gamma Knife PerfexionElekta Instrument AB / cleared 2007-03-05

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)