Events

Safety Alert for X-ray Intraoral System, Model CS 2100 and CS 2200 (Former KODAK 2100 and KODAK 2200), Registration No. 80378750002. Serial numbers: WEYA056, WEYA057, WEYA058, WEYA059, WEYA278, WEYA279, WEYA280, WEYA281, WEYA282, WFYA330, WFYA331, WFYA332, XCYA027, XCYA028, XEYA411, XEYA459, XEYA460, XHYC033, XHYC034, XHYC035, XIYC357, XIYC358, XIYC359, XIYC360, XJYC061, XJYC062, XJYC063, XJYC064, XJYC065, XJYC066, XLYC082, XLYC083, XLYC084, XLYC085, YBYC163, YBYC165, YBYC165, YBYC166, YBYC292, YBYC293, YBYC294, YBYC295, YBYC296, YBYC297, YBYC298

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CARESTREAM DO BRASIL COMERCIO E SERVIÇOS DE PRODUTOS MEDlCOS 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
    1385
  • Date
    2014-04-30
  • 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 the fault is not immediate and is usually visible to the user long before the arm can fall. Still according to the company, this can result in problem with the connection between the scissor arm and the support and there is likelihood of the scissor arm loosen. It also indicates that this is unlikely to occur, since when presenting the problem in its initial phase the arm movement will be restricted, allowing the identification of the movement anomaly. If the arm is released, there is a risk of injury to the patient or user.
  • Reason
    The company reports that the likelihood of early failure of the scissor arm support joint of the kodak 2100 and kodak 2200 equipment has been identified. carestream has identified a problem in the manufacturing process during the period from may 2008 to april 2010 that could result in the early failure of the connection of the scissor arm with the holder.
  • Action
    Carestream recommends that users make regular inspections of their equipment using the images in Annex IV to ensure the arm is not defective. If the equipment shows the first signs of failure in the inspection, the service should stop using it and contact the Technical Assistance by telephone 0800891 7554.

Device

X-ray Intraoral System, Model CS 2100 and CS 2200 (Former KODAK 2100 and KODAK 2200), Registratio...

Manufacturer

CARESTREAM DO BRASIL COMERCIO E SERVIÇOS DE PRODUTOS MEDlCOS LTDA.
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    ANVSANVISA