Events

Recall of Device Recall MOSAIQ Oncology Information Systems

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
    62302
  • Event Risk Class
    Class 2
  • Event Number
    Z-1944-2012
  • Event Initiated Date
    2012-06-08
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110188
  • 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
    Impac medical became aware of a problem with the recording of the wedge motor units in mosaiq when it resumes after a machine terminates/faults, the remaining wedge mu was being erroneously set to zero.
  • Action
    A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.

Device

Device Recall MOSAIQ Oncology Information Systems
  • Model / Serial
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • Product Description
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

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