Events

Safety Alert for Mammography Unit Graph-Mammo AF, registry: 10216710241, risk class III, Philips Brand; models: PABI8101001 / PACHD401001

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 Medical Systems.

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
    1557
  • Date
    2015-03-05
  • 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
    According to the registry holder, there is a low probability of this failure resulting in the breaking of the equipment bearing, which causes the arm to tilt about fifteen degrees toward the patient. If the event occurs during the examination, there is a risk of injury to the patient.
  • Reason
    Product received with broken bearing weld.
  • Action
    For safety reasons, according to the manufacturer, if the problem is detected in the equipment, an immediate suspension of use will be requested and the customer must request a repair appointment for the equipment by a qualified technician.

Device

Mammography Unit Graph-Mammo AF, registry: 10216710241, risk class III, Philips Brand; models: PA...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA