Events

Safety Alert for X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Registry nº10216710209, COMPUTERIZED TOMOGRAPHY EQUIPMENT Mx8000 DUAL vEXP PHILIPS BRAND, ANVISA Registry nº10216710142.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1232
  • Date
    2013-02-06
  • 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
    If the table is moved down unexpectedly, please discontinue use of the equipment and contact the Service Support of your local Philips equipment. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to sab from 7:00 a.m. to 7:00 p.m.
  • Reason
    Philips healthcare received field reports stating that the patient's desk in one system presented an unexpected descent movement while the patient was on it. philips has determined that the bed brake has malfunctioned due to deterioration of the vertical brake bolts. the following ct systems affected: • ct brilliance series: 6,10,16,16 power, 40, 64, big bore, big bore oncology, ict, ict sp, ingenuity core, ingenuity ct, mx8000 dual v. exp. there is a possibility that the vertical brake may fail while the patient is on the table and the table is raised. although no serious injury has been reported, if the vertical brake malfunctions, the technician, patient, or other persons near the table may be injured. system serial numbers brilliance ct 6 affected, access: http://portal.Anvisa.Gov.Br/wps/wcm/connect/109a64004e998c8aae88ae8a610f4177/aviso_de_seguranca_fco72800577.Pdf?mod=ajperes.
  • Action
    The Philips Equipment Service Engineer will perform the brake repair or replace the system to solve the problem.

Device

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Re...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA