Events

Rappel de CDI BLOOD PARAMETER MONITORING SYSTEM 500

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RYAN MEDICAL DISTRIBUTORS INC..

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
    38714
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-16
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Specific cdi blood parameter monitoring system 500 devices are being voluntarily recalled because the bpm sensor head assembly's thermistor which provides the blood temperature value that results in accurate display values on the monitor does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values on the cdi system 500 monitor. terumo cardiovascular systems (ryan medical distributors inc.) received complaints of inaccurate temperature measurements for specific devices distributed since november 5 2015. these include both new production devices and recently serviced devices.

Device

CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Modèle / numéro de série
    Model Catalog: 500AHCT (Lot serial: 3623); Model Catalog: 500AV (Lot serial: 3623); Model Catalog: 500AVHCT (Lot serial: 3623); Model Catalog: 500AHCT (Lot serial: 3030); Model Catalog: 500AVHCT (Lot serial: 3587); Model Catalog: 500AVHCT (Lot serial: 3030); Model Catalog: 500AHCT (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3030)
  • Description du dispositif
    CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.