Events

Retiro De Equipo (Recall) de Device Recall Ultraview SL Command Module

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, Llc.

¿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
    60593
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0690-2012
  • Fecha de inicio del evento
    2011-11-03
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105892
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    Nibp pump inside the ultraview sl command module, model 91496, became loose. the pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.
  • Acción
    SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engineer. Your field service engineer will be contacting you early in 2012 to schedule a mutually agreeable time to upgrade all of your affected modules. Upgrades will be performed on-site and at no cost to you. For any questions about this corrective action program, please call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support or, outside the United States, 1-425-657-7200 x5089.

Device

Device Recall Ultraview SL Command Module
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide)
  • Descripción del producto
    Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. || The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA