Events

Recall of Device Recall Medical linear acelerator (with patient imaging)

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
    60121
  • Event Risk Class
    Class 2
  • Event Number
    Z-0305-2012
  • Event Initiated Date
    2011-03-09
  • Event Date Posted
    2011-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104472
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    If "confirm" or "unconfirm" settings are clicked during the "terminated checking" phase of treatment delivery, desktop pro cancels the loaded beam and sets the beam mus to zero. desktop pro then sends the delivered mus to mosaiq a a zero value.
  • Action
    Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.

Device

Device Recall Medical linear acelerator (with patient imaging)
  • Model / Serial
    152019, 152448, 151076, 151954, 152454, 152117, 152452, 152393, 152394, 151942, 152163, 151955, 152176, 152222, 151931, 152388, 151141, 152365, 152303, 152358, 152353, 152359, 152352, 152362, 152305, 152468, 152481, 152469, 151812, 152432, 151260, 151952, 152370, 151396, 152301, 152248, 152425, 151155, 151156, 151157, 151412, 105984, 152307, 152308. 151443, 151545, 151628, 152207, 152271, 152373, 152371, 151080, 152211, 152158, 152392, 152331
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico
  • Product Description
    Elekta Synergy XVI 4.5 || Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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