Events

Retiro De Equipo (Recall) de RAPIDPOINT 500 SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    23408
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-07-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens has issued an urgent field safety notice to inform customers of potential when both ports (serial and ethernet) are configured to transmit data the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data missing data data from a different patient. siemens has not observed this scenario and the expected frequency of occurrence is extremely unlikely. if this issue occurs only one analyte has the potential to be affected (i.E. if a panel of analytes is ordered only one could be affected).

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: RAPIDPOINT 500 (Lot serial: ALL)
  • Descripción del producto
    RAPIDPOINT 500 SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC