Events

Recall of VIRIDIA COMPONENT MONITORING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH.

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
    103335
  • Event Risk Class
    III
  • Event Initiated Date
    2003-01-10
  • 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
    Higher levels of airway pressure (>25cmh20) during ventilation causes co2 artifact (blip)on the capnogram. artifact may result in inappropriate treatment of patient.

Device

VIRIDIA COMPONENT MONITORING SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: AUST L # 27429); Model Catalog: (Lot serial: SN 14873); Model Catalog: (Lot serial: 15381); Model Catalog: (Lot serial: 15131); Model Catalog: (Lot serial: 15117); Model Catalog: (Lot serial: 15121); Model Catalog: (Lot serial: 15124); Model Catalog: (Lot serial: 15103); Model Catalog: (Lot serial: 15109); Model Catalog: (Lot serial: 15286); Model Catalog: (Lot serial: 14977); Model Catalog: (Lot serial: 14951); Model Catalog: (Lot serial: 15353); Model Catalog: (Lot serial: 14742); Model Catalog: (Lot serial: 15379)
  • Product Description
    M1657B WATERTRAP (WITH AGM)
  • Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

Manufacturer

PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  • Manufacturer Address
    BOEBLINGEN
  • Source
    HC