Events

Alerta De Seguridad para Model: T2100, Brand: GE Healthcare, Register: 80071260189, T2100 Treadmills that use power cords with the following part numbers :. • 408930-001 REV E - manufactured from June 1, 2006 until December 10, 2014. If the cable has the RWK identification it means that it has already been inspected (SEE CUSTOMER'S CHART) ///. • 408930-002 REV C - manufactured from June 1, 2006 through January 19, 2015. ///. • 2028038-008 REV B - manufactured from December 1, 2006 through January 28, 2015.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Medical Systems Information Technologies, INC..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1531
  • Fecha
    2015-02-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to the registrant, as a consequence of the problem, electrical shock may occur under the three conditions listed below: 1) The power cord has a grounded connection. 2) When there is deterioration or loss of electrical insulation on some internal conductors that may come in contact with the chassis. 3) The patient or operator comes into simultaneous contact with the equipment and a path to the ground. #### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    The power cord attached directly to the t2100 treadmill may not have been mounted in accordance with the instructions resulting in a grounding compromise. the problem may lead to failure of the insulation of the power conductor generating energization of the conveyor chassis.
  • Acción
    The company instructs the user to perform the leakage current tests specified in the T2100 Treadmill Service Manual supplied as part of the product. If the results indicated are acceptable the company clarifies that the chassis is not energized and there is no failure in the test. If results are not acceptable, the user should discontinue use of the equipment and contact GE Technical Support for assistance. The company reinforces the guidance on performing routine maintenance on these equipment.

Device

Model: T2100, Brand: GE Healthcare, Register: 80071260189, T2100 Treadmills that use power cords ...

Manufacturer

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