Events

Recall of PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia 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-2016-RN-00040-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00040-2
  • 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
    A quality issue has been identified, relating to an incorrect power status indication with the ps900 power module supplied with the affected patient monitoring products. the products with the defective power module installed can generate false "battery low" alarms, and may have an incorrect power status shown on the screen.The battery cannot be used in its current state as it cannot be recharged. however, the products can continue to be used the by plugging them into main power.
  • Action
    The sponsor is advising users that the affected devices can continue to be used provided that they are connected to a main power. The sponsor will contact the affected users to arrange for a firmware upgrade and/or the replacement of the power module. This action has been closed-out on 16/05/2017.

Device

PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors
  • Model / Serial
    PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors Product code: ED-SE-1200E-BSerial numbers of the monitors affected:60531-M1590102000160531-M1590102000260531-M1590102000360531-M1590102000560531-M1590102000960531-M1590454000260531-M1590454000311076-M1590453000111076-M1590453000211076-M1590453000311076-M1590453000411076-M15904530005ARTG Numbers: 178086 and 236697
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd