Events

Alerte De Sécurité sur X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numbers: Attachment

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda.; Philips and Neusoft Medical Systems Co. LTD.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1483
  • Date
    2014-11-28
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The company informs that there is possibility of incorrect diagnosis or classification of incorrect anatomy, leading to treatment / procedure not necessary, although the probability of occurrence has been classified as not expected
  • Cause
    Philips informs that you have identified that the orientation of the images is displayed incorrectly. when the operator chooses "gantry on the right side" on the operation control panel, and the patient position is hfdl, hfdr, ffdl, or ffdr, the patient position figure and text are not compatible. "l" and "r" ("left" and "right") of the examination images are inverted and this is not compatible with the current position of the patient.
  • Action
    Philips Healthcare instructs that: 1. When the error is found, restart the Console and Application software. 2. Avoid using the "Gantry on the Right side" guideline to examine patients. 3. After the Console starts, wait a few minutes, and then start the application software. Further information in the annex: Safety Notice.

Device

X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numb...

Manufacturer

Philips Medical Systems Ltda.; Philips and Neusoft Medical Systems Co. LTD
  • Source
    ANVSANVISA