Events

Recall of Device Recall MOSAIQ 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
    Recall
  • Event ID
    61308
  • Event Risk Class
    Class 2
  • Event Number
    Z-1270-2012
  • Event Initiated Date
    2012-02-14
  • Event Date Posted
    2012-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107779
  • 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
    Images used in treatment planning may belong to another patient. risk of treatment to wrong area. software update to upgrade siemens installed base to the latest release of mosaiq version 2.00x3 sp5, for rt therapist version 2.1a.
  • Action
    Siemens sent a Customer Information letters to all affected customers. The Customer information letters inform customers of the release of MOSAIQ 2.00X3 SP5 which specifically addresses a safety issue that is only found when MOSAIQ is used with COHERENCE Therapist 2.1 MQ (also called RTT2.1A). This letter is to be kept with Customer information documentation. Update Instruction TH004/12S are being issued with the update. The Software update is delivered and installed by qualified Field Service Engineers. For questions, contact your responsible SIEMENS Service Engineer or Application Specialist.

Device

Device Recall MOSAIQ System;
  • Model / Serial
    MOSIAQ System model number 10568605.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of KY, PA, TN, WI, and P.R. and the countries of Australia, Belgium, Bosnia Herzeg. China, Colombia, Croatia, Czech Republic, Germany, India, Ireland, Japan, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Poland, Russian Federation, South Africa, Saudi Arabia, Thailand, Turkey, and United Kingdom.
  • Product Description
    MOSAIQ System; || customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. || MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. || Distributed by Siemens Healthcare, Concord, Ca. || Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. || P
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

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