Events

Recall of ProBP 2400 Digital Blood Pressure DeviceSerial

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Welch Allyn Australia Pty 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
    RC-2017-RN-00922-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00922-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Welch allyn has been made aware of a product quality issue which could potentially affect the probp 2400 digital blood pressure devices manufactured by microlife and distributed by welch allyn. 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.This issue may lead to patient and/or caregiver burns as result of skin contact with melted plastic and/or delays in treatment.
  • Action
    The affected devices within the Serial Numbers specified in the customer letter are being recalled and will be replaced with new devices at no cost to affected customers.

Device

ProBP 2400 Digital Blood Pressure DeviceSerial
  • Model / Serial
    ProBP 2400 Digital Blood Pressure DeviceSerial Number ranges:(21)07150001 – (21)07150620 (21)12150001 – (21)12150500 Please note: (21) is NOT part of the Serial Number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the Serial Number on any GUDI compliant label.ARTG Number: 232592
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited