Events

Recall of SmartMonitor 2 Professional Series

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-2014-RN-00585-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00585-1
  • 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
    Certain aaa backup battery packs may have been wired incorrectly. this wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up.
  • Action
    Philips is providing replacement battery packs for all units from the affected lots. This action has been closed-out on 11/02/2016.

Device

SmartMonitor 2 Professional Series
  • Model / Serial
    SmartMonitor 2 Professional SeriesBattery Part Numbers: 989805604231/1023384Battery Lot Numbers: TJ04170004 and TJ03190004ARTG Number: 177712
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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