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
    47475
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-22
  • 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
    Philips has become aware that the spo2 and non-invasive blood pressure (nibp) waveform and numeric values displayed on the device may freeze resulting in the display of measurements that are not current. although spo2 and nibp monitoring and alarms are no longer functional all other monitoring parameters are functional and visible. if this problem were to occur the device can be reset by power cycling and the reset will allow the customer to continue monitoring. however power cycling the device does not prevent the issue from recurring.

Device

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: FC2010 (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