Events

Retiro De Equipo (Recall) de Device Recall Siemens Healthcare Diagnostics

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Healthcare Diagnostics 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
    68437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2079-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127701
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acid, lactic, enzymatic method - Product Code KHP
  • Causa
    Rapidpoint 500 measurement cartridges may have an error code one or more electrolyte parameters (e.G., na+, ca++, k+, cl-).
  • Acción
    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.

Device

Device Recall Siemens Healthcare Diagnostics
  • Modelo / Serial
    Serial Numbers: 2334500011 through 2412705915
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
  • Descripción del producto
    RAPIDPoint 500 Measurement Clinical Chemistry System || RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) || Part number: 10491449; || RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) || Part Number: 10491448 || RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) || Part Number: 10491447 || RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) || Part Number:10844813
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA