Events

Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER

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
    127055
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-31
  • 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 healthcare diagnostics has received customer complaints of discrepant siemens healthcare diagnostics has received customer complaints of discrepant patient results on dimension vista intelligent lab systems. siemens healthcarepatient results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed a software defect which in a very specific set of circumstances results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system. omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.

Device

DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER
  • Modelo / Serial
    Model Catalog: 1000033793 (Lot serial: ALL); Model Catalog: 1000034648 (Lot serial: ALL)
  • Descripción del producto
    DIMENSION VISTA SYSTEM-DIMENSION VISTA 1500 ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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