Events

Recall of Device Recall LEKSELL GAMMAPLAN

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
    54890
  • Event Risk Class
    Class 2
  • Event Number
    Z-1604-2010
  • Event Initiated Date
    2008-01-07
  • Event Date Posted
    2010-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89388
  • 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
    system, radiation therapy, radionuclide - Product Code IWB
  • Reason
    The precision of the calculation used to create the fused study in lgp 8.0 is too low and should not be used until the system is upgraded to lgp 8.2.
  • Action
    Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, do not hesitate to contact your Elekta support respresentative at

Device

Device Recall LEKSELL GAMMAPLAN
  • Model / Serial
    2UA7361354, SG50425266, CZC75037DN, SG42820297, CZC707499P, SG34220707, CZC7044FLP, CZC7053FQD, CZC71228QT, CZC7354BN3, CZC740298, SG43520759, SG43720546, SG50825766, 2UA7291VKX, 2UA7291VJ3, US19378673, CZC354BN1, 0703150004, SG23320693, SG24820187, SG52720065, SG31620624, CZC70906S3, CZC70906SB, 2UA7361359, SG52720070, SG44925633, CZC70906S5, CZC7053FQ6, CZC706326M, 2UA736135C, 2UA7291VHT, SG34420200, SG32520836, 2UA7291VHY, 2UA7150VYH, SG43720660, CZC7481Q3R, SG50425271, SG50825764, US68115508, SG52720067, SG34620630, 2UA7251YHM, SG60320067, SG5272066, SG20620611, 2UA73317NW, SG41720274, SG41720317, SG31360678, SG40920412, SG31020317, SG33620363, SG24820212, CZC707499Q, CZC74024P9, SG42520530, CZC07031CRQ, CZC07031CRX, CZC70906S6, CZC70906S7, CZC7044FLN, SG50425273, SG50927332
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IL MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WA.
  • Product Description
    Leksell GammaPlan 8.0 image fusion || Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.
  • 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