Events

Avis De Sécurité sur Contec Devices including Pulse Oximeters, Patient monitors, Ambulatory Blood Pressure Monitors, Spirometers, Pocket fetal dopplers, B-Ultrasound Diagnostic Systems, ECG's

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Contec Medical Systems Co., Ltd. .

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2011(13)
  • Date
    2011-06-13
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contec-devices-including-pulse-oximeters-patient-monitors-ambulatory-blood-pressure-monitors-spirometers-pocket-fetal-dopplers-b-ultrasound-diagnostic-systems-ecg's&id=0285f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Non-compliant medical devices manufactured by contec medical systems have been supplied to customers in ireland. these devices do not bear the ce mark as required by the medical device legislation.
  • Action
    • Check if you have these devices in your institution.  • Examine the devices to confirm that they are CE marked.  • If the device or the User Manual does not bear the CE mark, please contact the manufacturer or your supplier. The manufacturer or supplier will provide details of the necessary actions required.

Device

Contec Devices including Pulse Oximeters, Patient monitors, Ambulatory Blood Pressure Monitors, S...
  • Modèle / numéro de série
  • Description du dispositif
    Contec Devices including Pulse Oximeters, Patient monitors, Ambulatory Blood Pressure Monitors, Spirometers, Pocket fetal dopplers, B-Ultrasound Diagnostic Systems, ECG's
  • Manufacturer
    Contec Medical Systems Co., Ltd. 

Manufacturer

Contec Medical Systems Co., Ltd.