Events

Recall of SureSigns VSi, VS2+SureSigns VSi - NBP

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-2017-RN-01263-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01263-1
  • 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 has identified that certain suresigns vsi, vs2+ products have the date of manufacture on its serial number label as “%dom”, instead of the specific date in the format of yyyy-mm.
  • Action
    1. Philips will provide affected customers with a new label with "Date of Manufacture" for each unit. An instruction will be provided to impacted customers on how to do the correction. 2. Philips Healthcare will contact customers impacted to arrange for the correction.

Device

SureSigns VSi, VS2+SureSigns VSi - NBP
  • Model / Serial
    SureSigns VSi, VS2+SureSigns VSi - NBPProduct Number: 863275SureSigns VSi - NBP/SPO2Product Number: 863276 SureSigns VSi - NBP/SPO2/Temp/WirelessProduct Number: 863277SureSigns VS2+ NBP/SPO2Product Number: 863278SureSigns VS2+ NBP/SPO2/WirelessProduct Number: 863279Multiple Serial NumbersARTG Number: 93971
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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