Events

Safety Alert for Trade name: Access Dual; ANVISA registration number: 10216710277; Risk class: III; Affected Model: Dual Access; Affected serial numbers: ADVE140003 and ADVE140004.

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
    1891
  • Date
    2016-05-04
  • 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
    Philips will release the Field Change Order (FCO) 72800628 to update the software free of charge, as soon as it is available a contact will be made with customers to schedule this fix. If you need more information or support for this issue, please contact our Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
  • Reason
    Problem 1: if a surview sweep, longer than 463 mm, is interrupted by the use of the pause button during the scanning process. problem 2: if any of these two surview scans are paused during the dual-surview scan, the location lines in the two surview scans will be misaligned. problem 3: in the case of dual-surview scanning, if the user presses the pause / stop button during the second surview scan, the position of the second surview image will not be consistent with the first surview image. problem 4: mark orientation is displayed incorrectly when scanner direction display is checked and the patient position is hfdl, hfdr, ffdl or ffdr. problem 5: during the printing operation in the console software, the clipboard used to copy and paste images is not cleaned (erased) between patients.
  • Action
    Action code FCO72800628. Recommendations to users and patients: Until the software is upgraded to v1.0.1.11449.

Device

Trade name: Access Dual; ANVISA registration number: 10216710277; Risk class: III; Affected Model...

Manufacturer

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