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
    55712
  • Event Risk Class
    Class 2
  • Event Number
    Z-0159-2011
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2010-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91633
  • 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, planning, radiation therapy treatment - Product Code MUJ
  • Reason
    Mistreatment-- the database conversion utility used during the upgrade errantly changes the start gantry angle to zero. any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
  • Action
    ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.

Device

Device Recall Elekta Impac Software Sequencer
  • Model / Serial
    Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
  • Product Description
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. || 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.
  • 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