Events

Recall of Vital Signs/GE General Purpose Temperature Probe, 9Fr

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Vital Signs 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
    15083
  • Event Initiated Date
    2013-08-01
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    Ge's disposable general purpose 9fr temperature probe m1024229 is intended for oro-esophageal and rectal use. as it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe nasally which may result in epistaxis (nosebleed). epistaxis can vary in severity and include severe bleeding that may require specialty (otolaryngology) care.
  • Action
    Instructions for use to be updated

Device

Vital Signs/GE General Purpose Temperature Probe, 9Fr
  • Model / Serial
    Model: Model: M1024229, Affected: All lots
  • Manufacturer
    Vital Signs Inc

Manufacturer

Vital Signs Inc