Events

Recall of Portapres NiMh battery pack (Device to continuously measure blood pressure)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ptronik Pty Ltd.

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-2012-RN-00705-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00705-3
  • 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
    Due to a production error the battery packs may become hot and start leaking when exposed to mechanical stress.This recall action was not notified to the tga before it was initiated by ptronik.
  • Action
    The sponsor is providing work around instructions and replacing all affected battery packs.

Device

Portapres NiMh battery pack (Device to continuously measure blood pressure)
  • Model / Serial
    Portapres NiMh battery pack (Device to continuously measure blood pressure)Batch number: 12 02 010, 12 02 011, 12 02 003ARTG: 138530
  • Manufacturer
    Ptronik Pty Ltd

Manufacturer

Ptronik Pty Ltd