Events

Safety Alert for 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)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Ultrasound, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1900
  • Date
    2016-04-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA