Events

Recall of SureSigns Patient Monitors, Model VS2+

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2013-RN-00129-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00129-1
  • 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
    Philips healthcare has identified that it is possible for the suresigns vs2+ patient monitor to lock up and stop monitoring during patient use.
  • Action
    Philips is advising end users to not use the device in non-invasive blood pressure (NBP) Interval mode. If the device freezes disconnect the power and remove the battery. Reconnect the battery and power-up after 60 seconds. Philips Healthcare is implementing a design change to correct the issue.

Device

SureSigns Patient Monitors, Model VS2+

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA