Device Recall PRIMEVIEW 3i System 2.0

  • Modèle / numéro de série
    Serial numbers associated with RTT2.0 and RTT2.1
  • Classification du dispositif
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 || Medical charged-particle radiation therapy system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1  Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Product distribution information pending from firm.
  • Description du dispositif
    Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
  • Manufacturer