Events

Safety Alert for X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numbers: Attachment

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 and Neusoft Medical Systems Co. LTD.

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
    1483
  • Date
    2014-11-28
  • 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
    The company informs that there is possibility of incorrect diagnosis or classification of incorrect anatomy, leading to treatment / procedure not necessary, although the probability of occurrence has been classified as not expected
  • Reason
    Philips informs that you have identified that the orientation of the images is displayed incorrectly. when the operator chooses "gantry on the right side" on the operation control panel, and the patient position is hfdl, hfdr, ffdl, or ffdr, the patient position figure and text are not compatible. "l" and "r" ("left" and "right") of the examination images are inverted and this is not compatible with the current position of the patient.
  • Action
    Philips Healthcare instructs that: 1. When the error is found, restart the Console and Application software. 2. Avoid using the "Gantry on the Right side" guideline to examine patients. 3. After the Console starts, wait a few minutes, and then start the application software. Further information in the annex: Safety Notice.

Device

X-ray System for Computed Tomography, Model MX 16-Slice, Registration nº 10216710193. Serial numb...

Manufacturer

Philips Medical Systems Ltda.; Philips and Neusoft Medical Systems Co. LTD
  • Source
    ANVSANVISA