Events

Recall of SOKINOX NO DELIVERING AND MONITORING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    72431
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-30
  • 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
    Due to a pressure increase after the cylinder switch-over there are 2 possible issues identified:1. the cylinder status icon can change and erroneously indicate remaining gas in an empty no(nitric oxide) gas cylinder. 2. the alarm "no cylinder 1 missing (or empty)" or "no cylinder 2 missing (or empty)" can be deactivated. if the empty no cylinder is not replaced both no cylinders can run empty and cause a stop in no delivery. there have been no reports of patient injury as a result of this issue.

Device

SOKINOX NO DELIVERING AND MONITORING SYSTEM
  • Model / Serial
    Model Catalog: 6694550 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    SOKINOX NO DELIVERING AND MONITORING SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC