Events

Rappel de Siemens

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    47773
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1769-2008
  • Date de mise en oeuvre de l'événement
    2007-10-03
  • Date de publication de l'événement
    2008-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70134
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Charged-Particle Radiation Therapy System - Product Code IYE
  • Cause
    Software. the firm issued an advisory letter update instruction th030/07/s as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. the advisory alerts all its affected customers of the image issue to prevent potential mistreatment.
  • Action
    Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.

Device

Siemens
  • Modèle / numéro de série
    Software Numbers 7358299, 7360857, and 8141835. Applies only to those parts used with the following devices: Coherence AG Therapist-5863506; Coherence Therapist System-7333680; Coherence Impression Therapist-7341410; PRIMEVIEW 3i-7341428; AG Therapist 3rd party V&R-7351898; Coherence Therapist 2.0-8139839 and PRIMEVIEW 3i 2.0-8139847.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.
  • Description du dispositif
    Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

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