Events

Recall of Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0

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-00026-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00026-1
  • 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 been made aware of a potential problem with all piic ix surveillance and patient link revisions. the issue will occur after a surveillance station is first restarted during the year 2018. after that initial restart, the station will thereafter no longer perform patient discharge and transfer operations. any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the surveillance station during such restart.
  • Action
    Philips is advising users that in order to avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. Users may use the workflows described in the attachment provided with the customer letter to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged.

Device

Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023...
  • Model / Serial
    Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0ARTG 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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