Events

Recall of S/5 COMPACT CRITICAL CARE MONITOR SYSTEM - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATEX-OHMEDA (CANADA) 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
    22551
  • Event Risk Class
    II
  • Event Initiated Date
    2002-01-08
  • 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
    Monitors with s/5 software of level 10.7 or lower may generate inaccurate arrhythmia alarms in the presence of electromagnetic interference might distort the measured ecg signal and arrhythmias.

Device

S/5 COMPACT CRITICAL CARE MONITOR SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: S-00C04 (Lot serial: S/NS: 4303100 4039913); Model Catalog: S-00C03 (Lot serial: S/NS: 4303100 4039913); Model Catalog: U-00C04 (Lot serial: 4303099 4303098 4352308.); Model Catalog: S-00C04 (Lot serial: 4303099 4303098 4352308.); Model Catalog: S-00C03 (Lot serial: 4303099 4303098 4352308.); Model Catalog: U-00C04 (Lot serial: 4303110 4038570 4038571); Model Catalog: S-00C04 (Lot serial: 4303110 4038570 4038571); Model Catalog: S-00C03 (Lot serial: 4303110 4038570 4038571); Model Catalog: S-00C01 (Lot serial: 4261771 4227756 4354079); Model Catalog: S-00C01 (Lot serial: S/NS: 4310404 4037459); Model Catalog: U-00C02 (Lot serial: 4336736 4037458 4353822.); Model Catalog: U-00C01 (Lot serial: 4336736 4037458 4353822.); Model Catalog: S-00C02 (Lot serial: 4336736 4037458 4353822.); Model Catalog: S-00C01 (Lot serial: 4336736 4037458 4353822.); Model Catalog: U-00C02 (Lot serial: 4336733 4336734 4336735); Model Catalog: U-00C01 (Lot serial: 4336733 4336734 4336735); Model Catalog: S-00C02 (Lot se
  • Product Description
    CRITICAL CARE MONITOR
  • Manufacturer
    DATEX-OHMEDA (CANADA) INC.

Manufacturer

DATEX-OHMEDA (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC