Events

Safety Alert for Trade name: GE T2100 Ergometer Treadmill. Technical Name: Treadmill. ANVISA Registration Number: 80071260189. Hazard Class: I. Affected Model: GE T2100 Ergometer Treadmill. Batch / Affected Series Numbers: GE T2100 Ergometer Treadmill

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda; GE Healthcare Critikon de Mexico S de RL de CV.

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
    2553
  • Date
    2018-04-20
  • 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
    For the recommendations given by the company, access the letter to the customer available at: LINK: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2553-tecnovigilancia-ge-healthcare -file-ergometer-ge-t2100-installation-of-parts-reserve-may-result-in-motion-off-the-tape-d / 33868? p_p_auth = bSxZsrle & inheritRedirect; = false & redirect; = http% 3A% 2F% 2Fportal If you want to notify technical and technical complaints, please contact us at the following link: adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Vigilance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of notification notice to Anvisa: 04/18/2018 The company holding the record of the affected product is responsible for contacting its clients in a timely manner to ensure the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    The t2100 treadmill performance problem with customer proprietary spare parts (2026182-002 or 2026182-004) was not solved with the previous safety fix (gehc fmi 30074). if these parts were installed from the customer's reserve stock on the t2100 treadmill, uncontrolled movement of the locomotive strap may occur during the exercise test exercise. this movement may be seen as an unexpected slowdown, followed by a sudden acceleration of the belt in forward or backward direction. when this occurs, even when the stop button is pressed, the movement of the strap does not stop immediately. instead, it will stop in up to 35 seconds by slowing down the maximum speed. sudden change in speed and / or belt direction can result in falls and injuries to the patient.
  • Action
    Field Action Code IMF 30085 triggered under the responsibility of the company GE Healthcare do Brasil, Com. for Equipos Médico-Hospitalares Ltda. Field correction.

Device

Trade name: GE T2100 Ergometer Treadmill. Technical Name: Treadmill. ANVISA Registration Number: ...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda; GE Healthcare C...