Recall of Device Recall MOSAIQ Oncology Information System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Reason
    The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
  • Action
    Sent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.


  • Model / Serial
    Part # 10568605
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    International Only Distribution -- Germany and Japan
  • Product Description
    MOSAIQ Oncology Information System || Intended Use : Electronic Patient Records Management
  • Manufacturer


  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source