Events

Recall of PHILIPS NM3 MONITOR MODEL 7900 - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS NOVAMETRIX LLC.

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
    31179
  • Event Risk Class
    I
  • Event Initiated Date
    2011-09-23
  • 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
    Some units exhibit a mechanical problem that could result in the display of incorrect tidal and minute volumes. inaccurate data could lead to an incorrect treatment for mechanically ventilated patients. this can lead to high pco2 and low ph level in the patient.

Device

PHILIPS NM3 MONITOR MODEL 7900 - MAIN UNIT
  • Model / Serial
    Model Catalog: 1051674 (Lot serial: 00409); Model Catalog: 1051674 (Lot serial: 00428); Model Catalog: 1051674 (Lot serial: 00350)
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Philips NM3 Monitor
  • Manufacturer
    RESPIRONICS NOVAMETRIX LLC

Manufacturer

RESPIRONICS NOVAMETRIX LLC
  • Manufacturer Address
    WALLINGFORD
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC