Events

Alerte De Sécurité sur Trade name: Ultrasound Equipment for EPIQ Diagnosis; ANVISA registration number: 10216710275; Risk class: II; Model Affected: EPIQ 5; Serial numbers affected: US814C0626; US814C0627; US914C0017; US914C0261; USO14C0601; USO14C0603; USO14C0602; USO14C0604; USO14C0605; USO14C0606; US215C0175; US215C0431; US215C0434; US215C0432; US215C0433; US215C0430; US315C0757; US315C0758; US315C0759; US315C0751; US315C0752; US315C0755; US315C0754; US315C0753; US315C0954; US415C0448; US515C0689 (SCHEDULE OF DISTRIBUTION IN ANNEX)

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 Ultrasound, Inc..

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
    1900
  • Date
    2016-04-17
  • 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
    Philips will contact all EPIQ customers to provide replacement service for the connection bolts from the control panel frame to the system by means of bolts less likely to come loose with repeated handling. This service will be provided free of charge. Should you require any additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Attendance from Monday to Saturday from 07h to 19h. ### UPDATE on 06/30/2017, the Action was finalized by the company according to the completion report sent.
  • Cause
    The control panel structure of the philips epiq ultrasound system can come loose, with the possibility of this structure detaching from the system. philips will contact you to make the necessary repairs to your system. (letter to the clients in annex).
  • Action
    Field Correction by replacing the connection bolts of the control panel frame to the system by bolts less likely to come loose with repeated handling; Field action code: FCO79500381; Recommendations to Users and Patients: If, at any time, the control panel structure of your ultrasound system oscillates or appears to be loose, immediately stop using your system and contact your local Philips representative or the Solution Center Philips at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. Otherwise, you can continue using your system.

Device

Trade name: Ultrasound Equipment for EPIQ Diagnosis; ANVISA registration number: 10216710275; Ris...

Manufacturer

Philips Medical Systems Ltda.; Philips Ultrasound, Inc.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA