Events

Retiro De Equipo (Recall) de Tourniquet Systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Zimmer Surgical, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    21816
  • Fecha de inicio del evento
    2017-08-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • Causa
    In a typical or setting, the manufacturer originally recommended a minimum separation distance of 3.8 meters (m) between rf communication equipment to mitigate the potential for electromagnetic interference and to achieve optimal performance of the tourniquet machines. rf equipment consists of, but is not limited to, electrosurgical equipment, including any consoles, wiring, and pencil units. this distance recommendation originates from iec 60601-1-2. as a result of customer feedback, additional internal testing was performed to see if this distance could be shortened, and it was determined that 1.0 meter provided adequate distance to avoid interference.
  • Acción
    Instructions for use to be updated

Device

Tourniquet Systems
  • Modelo / Serial
    Model: , Affected: updating an on-device label on ATS2200 and ATS4000 units
  • Manufacturer
    Zimmer Surgical, Inc.

Manufacturer

Zimmer Surgical, Inc.
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NZMMDSA