Events

Rappel de Device Recall Command Module

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Incorporated.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    48759
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2343-2008
  • Date de mise en oeuvre de l'événement
    2008-07-22
  • Date de publication de l'événement
    2008-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72427
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Arrhythmia Detector and alarm - Product Code DSI
  • Cause
    Potential for module to fail to obtain a nibp reading on hypertension patients.
  • Action
    On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.

Device

Device Recall Command Module
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product is distributed nationwide and internationally to medical facilities.
  • Description du dispositif
    Ultraview SL Command Module, Model 91496 || The product is intended for use with the Patient Care Monitoring 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 cardiac activity, respiration, invasive and noninvasive pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Adresse du fabricant
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA