Z-1158-2010

Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of...

Name: Z-1158-2010 Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of...
Creator: Elekta, Inc.
Published: 2007-07-02
License: https://open.fda.gov/license/

Elekta Limited / initiated 2007-07-02 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target... on 2007-07-02. The reason FDA records is "Need to modify the closing speed of the shielding doors in the event of an emergency exit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1158-2010
Status: Terminated
Initiated: 2007-07-02
Posted: 2010-03-17
Terminated: 2010-03-25
Recalling firm: Elekta Limited
Product: Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Need to modify the closing speed of the shielding doors in the event of an emergency exit
FDA root cause: Other
Action: A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
Quantity in commerce: 19
Distribution: Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
Product codes and lots: Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.

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)