Events

Recall of Radionuclide Radiation Therapy System

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
    54850
  • Event Risk Class
    Class 2
  • Event Number
    Z-1533-2010
  • Event Initiated Date
    2006-09-01
  • Event Date Posted
    2010-04-29
  • 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=89324
  • 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
    Leksell gamma knife c 1.2 with mcu version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. lock did not fully engage and could still be raised. when the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.
  • Action
    Phase 1 - Field Change Order FCO-DOC-06-0003 "Technical Note - Potential risk of dropping the collimator helmet" (dated Aug. 28, 2006) was sent to affected customers as notification of the problem. Phase 2 - Technical Notes Leksell Gamma Knife C version 1.2 (dated July 2006) "Important Notice - Potential risk of dropping the collimator helmet" was sent to all Elekta Service Engineers as notification of the problem. The firm planned to create an upgrade kit for the effected Leksell Gamma Knife C1.2 systems. A service representative from Elekta will contact each site to decide on a suitable implementation schedule.

Device

Radionuclide Radiation Therapy System
  • Model / Serial
    4149, 4150, 4151, 4157, 4158, 4160, 4151, 4165, 4168, 4171, 4175, 4176, 4178, 4183, 4187, 4189, 4191, 4193, 4194, 4195, 4196, 4197, 4199, 4201, 4202, 4204, 4207, 4208, 4212, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4328, 4329, 4334, 4337, 4802, 4809, 4816, 4817, 4818, 4824, 4828, 4830, 5000, 5003, 5006, 5009, 5010, 5001, 4803, 4310, 4210, 4311, 4330, 5004, 5014, 4305, 4320, 4317, 4324, 4325, 5011, 5012, 4304, 4316, 5002, 5007, 5008, 5013, 4819, 4806, 5005, 4301, 4323, 4312
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Austria, Belgium, Canada, China, Croatia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey.
  • Product Description
    Leksell Gamma Knife C
  • 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