Events

Safety Alert for X-ray apparatus, Compact Plus, Risk class III, registration 10216710251, series / lots affected 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 Medical Systems Ltda..

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
    1632
  • Date
    2015-07-03
  • 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 information of the holder, in the event of cable breakage and failure of the rubber safety lock, the assembly may slide along the column without speed control, depending on the degree of elevation. In this case the patient under procedure would be exposed to the risk of an adverse event. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of exchange, as planned.
  • Reason
    According to the record holder, there is a possibility that the steel cable component, used to lift the suspension mass of the arm assembly, x-ray tube and collimator, can break after a period of heavy equipment use due to the continuous contact with some mechanical parts inside the stationary (spring or motorized) column.
  • Action
    The company issued two safety notices. For customers who received the 001 (FSN) notice, the recommendation is to discontinue use of the equipment and wait for a preliminary inspection of the cable for action by the field engineer. For customers who received the 002 (FSN) communiqué, the equipment will not need to be interrupted and customers should wait for the scheduling of the service by the field engineer to exchange the parts involved

Device

X-ray apparatus, Compact Plus, Risk class III, registration 10216710251, series / lots affected i...

Manufacturer

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