Device Recall LANTIS Oncology Information System

  • Modèle / numéro de série
    versions 8.3, CD# 9, 10 and 11, part numbers 8149259, 8164787, 8166527
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including DE, WI, TX, TN, NJ, PA, NE, MA, and AL and the countries of South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan.
  • Description du dispositif
    LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA || Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.
  • Manufacturer
  • 1 Event

Fabricant

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