Device Recall MOSAIQ System;

  • Model / Serial
    MOSIAQ System model number 10568605.
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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