Events

Rappel de Device Recall ApexPro FH Telemetry System

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 Ge Healthcare.

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
    35826
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0054-2007
  • Date de mise en oeuvre de l'événement
    2006-06-23
  • Date de publication de l'événement
    2006-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46967
  • 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
    Telemetry System - Product Code MHX
  • Cause
    System warning alarm failure: when a patient being monitored is in a pre-existing condition of continuous message or advisory level alarm preceding a system warning level alarm, the system warning audible alarm and flashing yellow border around the patient panel at the cic does not occur.
  • Action
    An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.

Device

Device Recall ApexPro FH Telemetry System
  • Modèle / numéro de série
    Software versions v3.8 and earlier.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
  • Description du dispositif
    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Adresse du fabricant
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA