Events

Alerte De Sécurité sur X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Registry nº10216710209, COMPUTERIZED TOMOGRAPHY EQUIPMENT Mx8000 DUAL vEXP PHILIPS BRAND, ANVISA Registry nº10216710142.

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..

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
    1232
  • Date
    2013-02-06
  • 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
    If the table is moved down unexpectedly, please discontinue use of the equipment and contact the Service Support of your local Philips equipment. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to sab from 7:00 a.m. to 7:00 p.m.
  • Cause
    Philips healthcare received field reports stating that the patient's desk in one system presented an unexpected descent movement while the patient was on it. philips has determined that the bed brake has malfunctioned due to deterioration of the vertical brake bolts. the following ct systems affected: • ct brilliance series: 6,10,16,16 power, 40, 64, big bore, big bore oncology, ict, ict sp, ingenuity core, ingenuity ct, mx8000 dual v. exp. there is a possibility that the vertical brake may fail while the patient is on the table and the table is raised. although no serious injury has been reported, if the vertical brake malfunctions, the technician, patient, or other persons near the table may be injured. system serial numbers brilliance ct 6 affected, access: http://portal.Anvisa.Gov.Br/wps/wcm/connect/109a64004e998c8aae88ae8a610f4177/aviso_de_seguranca_fco72800577.Pdf?mod=ajperes.
  • Action
    The Philips Equipment Service Engineer will perform the brake repair or replace the system to solve the problem.

Device

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Re...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA