Events

Recall of Medical linear accelerator (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
    56753
  • Event Risk Class
    Class 2
  • Event Number
    Z-0350-2011
  • Event Initiated Date
    2010-09-01
  • 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=94450
  • 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
    It is possible to do couch corrections twice if both couch move assistant in mosaiq and remote automatic table in xvi are configured when in synergistiq mode.
  • Action
    Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401. If you have any questions contact your local service representative at +44(0)1293 654200.

Device

Medical linear accelerator (with patient imaging)
  • Model / Serial
    Serial Numbers 152019, 151866, 151259, 151522, 151969, 152192, 152126, 152115, 152116, 152176, 151931, 152177, 151523, 151626, 151842, 152158, 152079, 152080, 151250, 152064, 152207, 151628, and 151362
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AZ, CA, DC, IL, KY, MA, MI, MS, NV, NY, OH, OR, PA, VT, and WV.
  • Product Description
    Elekta Synergy XVI || Intended use: 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