Z-1236-2010

Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic...

Name: Z-1236-2010 Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic...
Creator: Elekta, Inc.
Published: 2007-10-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2007-10-01 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures on 2007-10-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1236-2010
Status: Terminated
Initiated: 2007-10-01
Posted: 2010-04-13
Terminated: 2010-12-28
Recalling firm: Elekta Limited
Product: Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
Product code: IWB System, Radiation Therapy, Radionuclide
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 root 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.
Product codes and lots: LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.

Product code IWB

K984328Class IILeksell Gamma Knife Target System, Model 24001Elekta Instrument AB / cleared 1999-05-21

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)