Events

Safety Alert for Commercial Name: Juno DRF Diagnostic X-ray Equipment Technical Name: Fluoroscopic X-Ray System ANVISA Registration Number: 10216710270 Hazard Class: III Affected Model: N / A Serial Number Affected: 16111583

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda; Villa Sistemi Medicali S.p.A..

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
    2242
  • Date
    2017-03-21
  • 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
    Do not use the footrest until the screws that hold the foot are checked by a technician.
  • Reason
    The footrest of the equipment was detached from the table top because the safety screws were discarded in the installation. the purpose of these screws is to prevent the footrest from completely separating from the table to prevent the patient from falling.
  • Action
    Field Action Code FCO70900035 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will do stock verification.

Device

Commercial Name: Juno DRF Diagnostic X-ray Equipment Technical Name: Fluoroscopic X-Ray System AN...

Manufacturer

Philips Medical Systems Ltda; Villa Sistemi Medicali S.p.A.
  • Source
    ANVSANVISA