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
    62619
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-21
  • 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
    Because of intermittent communication between the host system and teh flex cardio it is possible for any of the following conditions to occur: - boom monitor (display) may not display all active waveform and/or vital sign data. - delayed audible and visual alarms at the flex cardio and boom monitor respectively due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor. - after patient admission and case initiation at the host system the case may not be fully transmitted to the flex cardio. in this case the boom monitor in the exam/procedure room will display vital sign data but the flex cardio will not provide audible alarms. - after patient discharge and case termination at the host system case termination may not be transmitted to the flex cardio. in this case the boom monitor in the exam/procedure room will continue to display vital sign data and the flex cardio will continue to provide audible alarms.

Device

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: FC2010 (Lot serial: >10 numbers contact mfg); Model Catalog: FC2020 (Lot serial: >10 numbers contact mfg)
  • 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