Events

Alerta De Seguridad para Ultra PC% Cabinet Mount Flowmeters

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Accutron 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
  • Fecha
    2012-10-08
  • Fecha de publicación del evento
    2012-10-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121008.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: accutron ultra pc% cabinet mount flowmeters the united states food and drug administration (fda) has posted a firm press release concerning ultra pc% cabinet mount flowmeters, manufactured by accutron inc. accutron, inc., issued a nationwide recall of two hundred and six (206) ultra pc% cabinet mount flowmeters. some of the flowmeters have been found to release nitrous oxide gas when the oxygen is turned off. a flowmeter releasing nitrous oxide gas without oxygen could potentially lead to serious injuries like brain damage in patients. only two complaints have been received regarding the above described flowmeter defect. no injuries have been reported to date. the recall includes the following product model numbers: 27025 flowmeter, cm assy 36600-ns ultra pc% cabinet mount package g, no shut offs: 36800-ns ultra pc% cabinet mount package h, no shut offs 36600 ultra pc% cabinet mount package g 36700 cm flowmeter package h 5000 newport flowmeter system 36800 ultra pc% cabinet mount package h 31970 flowmeter cm consumers who have these flowmeters which are being recalled should stop using and return these flowmeters to accutron for free replacement. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm322799.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 october 2012.

Device

Ultra PC% Cabinet Mount Flowmeters
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Accutron Ultra PC% Cabinet Mount Flowmeters
  • Manufacturer
    Accutron Inc

Manufacturer

Accutron Inc