Events

Recall of SENTEC DIGITAL MONITORING SYSTEM - V-SIGN MEMBRANE CHANGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MCARTHUR MEDICAL SALES 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
    60492
  • Event Risk Class
    III
  • Event Initiated Date
    2013-01-25
  • 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 manufacturing defect that occurred for certain inserts no electrolyte will be present under the new membrane if a membrane changer with such an insert was used to change the membrane and electrolyte. the pco2 performance of a sensor without electrolyte will be deteriorated. during a subsequent use built-in sensor diagnostics in most cases will trigger appropriate alarms/messages and replace pco2 readings by "----" or mark them to be unstable or questionable.

Device

SENTEC DIGITAL MONITORING SYSTEM - V-SIGN MEMBRANE CHANGER
  • Model / Serial
    Model Catalog: VS-MCI (Lot serial: 1D58); Model Catalog: VS-MCI (Lot serial: 1D80)
  • Product Description
    SenTec V-Sign Membrane Changer (VSMC)
  • Manufacturer
    MCARTHUR MEDICAL SALES INC.

Manufacturer

MCARTHUR MEDICAL SALES INC.