Events

Recall of IntelliSpace Critical Care & Anaesthesia Information Systems

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-2015-RN-00097-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00097-1
  • 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
    A software configuration defect has been identified that impacts one standard content (configuration that is shipped with the product) unit of measure (gm/m2) for the body surface area (bsa). the defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. if the user does not identify that an incorrect multiplier exists in the standard content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).
  • Action
    Users are advised to implement the instructions in the customer letter if the BSA (gm/m2) Standard Content is used in their systems configuration. Philips has initiated a software correction to address this issue. A Philips representative will contact customers to schedule the implementation of this correction. This action has been closed-out on 20/07/2016.

Device

IntelliSpace Critical Care & Anaesthesia Information Systems
  • Model / Serial
    IntelliSpace Critical Care & Anaesthesia Information SystemsAffected Models:865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E866072 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. F866148 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. GARTG Number: 98511
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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