Events

Alerta De Seguridad para STERRAD NX System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Advanced Sterilization Products.

¿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
    2017-01-10
  • Fecha de publicación del evento
    2017-01-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170110b.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: advanced sterilization products sterrad nx system medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its sterrad nx system [part number: 10033, 10033-022]. the manufacturer has identified that in a rare sequence of events following an external power outage, the system door interlock can become disengaged during system reboot for a 20-second duration. the manufacturer is sending this medical device safety alert to remind customers to follow the instructions in the sterrad nx system user’s guide. specifically, after cycle initiation, the user should only open the chamber door of the sterrad nx system when prompted by the graphical user interface (gui) per the user’s guide. the manufacturer advises users to follow the instructions in the user’s guide, chapter 5 for normal operation. specifically, after cycle initiation, the user should only open the chamber door of the sterrad nx system when prompted by the gui per the user’s guide. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.

Device

STERRAD NX System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD NX System
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products