Events

Recall of Device Recall Leksell SurgiPlan

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55144
  • Event Risk Class
    Class 2
  • Event Number
    Z-1428-2010
  • Event Initiated Date
    2005-05-23
  • Event Date Posted
    2010-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radionuclide radiation therapy system - Product Code HAW
  • Reason
    Images from a different patient can be imported without a warning for the user.
  • 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..

Device

Device Recall Leksell SurgiPlan
  • Model / Serial
    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 Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Mexico.
  • Product Description
    Leksell SurgiPlan
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA