Events

Recall of SureSigns VSi, VS2+ products

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-2018-RN-00177-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00177-2
  • 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
    Phillip has identified that certain suresigns vsi, vs2+ products labels have a printing error on the date of manufacture.This action supersedes rc-2017-rn-01263-1 regarding an error in printing of the date of manufacture on the same devices.
  • Action
    Philips is advising that the affected products may continue to be used because this Date of Manufacture information on the serial number label, does not impact any of device function or operation. Philips will provide a new label with no printing error for the Date of Manufacture for each affected unit. An instruction will be provided to the impacted customers on how to perform the correction. A Philips Healthcare representative will contact users to arrange for the correction.

Device

SureSigns VSi, VS2+ products
  • Model / Serial
    SureSigns VSi, VS2+ products All devices manufactured between December 15, 2016 and May 02, 2017Model: SureSigns VSi - NBPProduct: 863275Model: SureSigns VSi - NBP/SPO2Product: 863276Model: SureSigns VS2+ NBP/SPO2Product: 863278Multiple affected serial numbersARTG: 93971Philips Electronics Australia Patient monitor, multiparameter
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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