Events

Recall of XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76348
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    While in full disclosure (fd) playback a user may inadvertently close the full disclosure control window using the esc key function instead of pressing the "x" icon in the upper right corner of this window. use of the esc key function will close the full disclosure control window but full disclosure waveforms and numerics will remain on the display (i.E. the system will remain in full disclosure playback mode) preventing the display of real-time waveforms numerics and any visual alarms. pendant la lecture avec divulgation totale un utilisateur pourrait fermer par inadvertance la fenetre de controle de divulgation totale avec la touche esc au lieu d'appuyer sur l'icone < x > dans le coin superieur droit de cette fenetre. l'utilisation de la touche esc fermera la fenetre de controle de divulgation totale mais les formes d'onde et les valeurs de la divulgation totale resteront a l'ecran (c'est-a-dire que le systeme restera en mode de lecture avec divulgation totale) empechant l'affichage en temps reel des formes d'onde des valeurs et de toute alarme visuelle.

Device

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: FC2020 (Lot serial: ALL)
  • Product Description
    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC