Events

Rappel de GE ApexPro Oximeter

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 General Electric Medical Systems Information Technology.

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
    53980
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0631-2010
  • Date de publication de l'événement
    2010-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86981
  • 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
    oximeter - Product Code DQA
  • Cause
    Potential misuse of the apexpro telemetry system and incorrect message and alarm information in the apexpro operator's manual may impact patient safety. when apexpro telemetry systems are used with spo2 oximeters: 1. apexpro fh transceiver can operate with the apexpro fh xpod connected, but without ecg lead wires attached to the transceiver. this is unintended use of the device that is not do.
  • Action
    Consignees were sent on 10/27/09 a GE Healthcare "Urgent Medical Device Correction" letter dated September 25, 2009. The letter was addressed to Risk Manger, Chief of Nursing, director of Biomedical Engineering. The letter described the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. "ApexPro Telemetry System Operator's Manual Supplement for SpO2 was enclosed with the letter.

Device

GE ApexPro Oximeter
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • Description du dispositif
    GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
  • Manufacturer
    General Electric Medical Systems Information Technology

Manufacturer

General Electric Medical Systems Information Technology
  • Adresse du fabricant
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA