Z-1428-2010

Leksell SurgiPlan

Name: Z-1428-2010 Leksell SurgiPlan
Creator: Elekta, Inc.
Published: 2005-05-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2005-05-23 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell SurgiPlan on 2005-05-23. The reason FDA records is "Images from a different patient can be imported without a warning for the user". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1428-2010
Status: Terminated
Initiated: 2005-05-23
Posted: 2010-04-22
Terminated: 2010-12-14
Recalling firm: Elekta Limited
Product: Leksell SurgiPlan
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Images from a different patient can be imported without a warning for the user.
FDA root cause: Other
Action: Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..
Quantity in commerce: 57 units
Distribution: Nationwide, Canada and Mexico.
Product codes and lots: US68104248, SG50425261, US68154313, US66320311, 3415G15729, 3416G05185, SW ONLY, 3416G07810, 3416G08464, US19311023, SG5121735, SG44720158, 000000000000010, SG33221023, 000000000000015, SG41020267, US19477688, SG14720637, SG31020878, SG21220437, IE24488098, SG11720734, US6836799, SG20220679, US68064889, US19344670, SG41720337, SG44820136, US6863578, US68247174, SG20220701, 000000000000011, 6458A30012, HP715/80, 000000000000019, 3628G06513, SG5020708, SG31120383, LGP-SG13420315, 000000000000014, 00000000000004, 3711C04231, US68154724, C160, SG33820630, 00000000000002, 000000000000013, 6146A06124, SG41920535, 6513A30173, 0304011939, A4986A, SG20220694, 000000000000016, SG20220699, 6601A30228, US19476876

Product code HAW

K943468Class IILeksell SurgiplanElekta Instruments, Inc. / cleared 1995-01-20

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)