Recall of PROPAQ LT MONITOR WITH WIRELESS RADIO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WELCH ALLYN CANADA LIMITED.

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
    43160
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-01
  • Event Country
  • 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
    Fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could in rare instances potentially interrupt propaq lt device operations. if this unlikely event were to occur the device would either present an error screen instructing the user to restart the monitor or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights and in either case the issue would be resolved by restarting (power cycling) the monitor. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.

Device

  • Model / Serial
    Model Catalog: 802LTAN (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 802LT0N (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 802LTRN (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Product Description
    PROPAQ LT 802LTAN
  • Manufacturer

Manufacturer