Events

Recall of Pro BP Handheld BP Device

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Welch Allyn 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
    21735
  • Event Initiated Date
    2017-07-28
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Reason
    The manufacturer has been made aware of an issue which could potentially affect the probp 2400 digital blood pressure. as a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery. the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.
  • Action
    Product to be exchanged

Device

Pro BP Handheld BP Device
  • Model / Serial
    Model: , Affected: Serial Numbers (21)12150001 - (21)12150500
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc