Events

Retiro De Equipo (Recall) de Device Recall Medical Integrated Multiparameter: Temperature Probe Adaptor

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 Spacelabs Healthcare, Incorporated.

¿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
    48744
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2314-2008
  • Fecha de inicio del evento
    2008-07-02
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72041
  • 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
    Multiparameter Monitor - Product Code DSI
  • Causa
    Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.
  • Acción
    Starting July 3, 2008 the firm issued a "MEDICAL DEVICE CORRECTION" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter that is being recalled. Technical Support will be available for customer questions and technical questions and to ensure each unit is upgraded. Contact Spacelabs Healthcare at 425-657-7200 ext 5970 if you have questions.

Device

Device Recall Medical Integrated Multiparameter: Temperature Probe Adaptor
  • Modelo / Serial
    Lot numbers: OSC 01/07, OSC 02/07, OSC 03/07, OSC 04/07 and OSC 07/07.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Worldwide to medical facilities.
  • Descripción del producto
    Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA"
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Dirección del fabricante
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA