Events

Recall of Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Welch Allyn Protocol 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
    15629
  • Event Initiated Date
    2013-11-15
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Reason
    Internal serial testing has identified fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this were to occur the device would either present an error screen instructing the user to restart the monitor, or could present a blank screen or white screen.Either screen would be accompanied by one or more blimking led lights, and in either case, the isue would be resolved by restarting (power cycling) the monitor.
  • Action
    Software to be upgraded

Device

Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

Manufacturer

Welch Allyn Protocol Inc