Events

Recall of Device Recall Elekta Impac Software Sequencer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impac Medical Systems 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
    58186
  • Event Risk Class
    Class 2
  • Event Number
    Z-2662-2011
  • Event Initiated Date
    2011-03-10
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98621
  • 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
    There's a problem in the database conversion program that is used when upgrading from the multi-acc¿s to mosaiq or from one version of mosaiq to another. if the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.
  • Action
    The firm, Elekta, sent a "USER NOTICE" to its customers with an attached confirmation of receipt form. The notice describes the product, problem and actions to be taken. The customers were instructed to follow the Interim mitigation instructions noted in the notice -verify the Arc start angle of the Simple ARC with MLC treatment field definition prior to delivery and if the customer identifes a field with an errant gantry start angle, to cease using that plan immediately and consult with the original plan for that field and make the correction to the gantry start angle. In addition, the customers were instructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at their organization who are potentially affected by this issue. For questions or requests for upgrade, email support@impac.com (North America/Asia) or europe.support@impac.com (Europe) or call USA 1-800-488-4672.

Device

Device Recall Elekta Impac Software Sequencer
  • Model / Serial
    MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of Canada.
  • Product Description
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ || The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Manufacturer Address
    Impac Medical Systems Inc, 100 Mathilda Pl Fl 5th, Sunnyvale CA 94086-6076
  • Manufacturer Parent Company (2017)
    Impac Medical Systems Inc
  • Source
    USFDA