Events

Recall of Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & IntelliSave AX700

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Proact Medical Systems (Australia) Pty 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-00126-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00126-1
  • 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
    The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. it can be brought up to working condition again by simply pulling it out. the control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user. for siesta i breasy, siesta i whispa and mri 508 freshgas regulation and ventilator mode change (manual or ventilator) can still be done as this is mechanical and/or soft key controlled and doesn’t need confirmation by the control dial.For siesta i ts and intellisave ax700 it is not possible to regulate freshgas delivery or change ventilator mode as this needs confirmation by the control dial.For all machine types ventilation will continue at the previously set parameters.
  • Action
    Device Technologies is requesting all its customers to check their machines for the faulty control dial and is replacing control dials on devices exhibiting the issue. End users are provided work around instructions to assist in the continued use of affected units. The anesthesia machine can continue to be used as the control dial can be pulled out, making the control dial work. This action has been closed-out on 08/08/2016.

Device

Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & Inte...
  • Model / Serial
    Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & IntelliSave AX700Siesta i BreasyProduct Numbers: 866204/10652-00Siesta i WhispaProduct Numbers: 866202/10651-00Dameca MRI 508 Product Numbers: 866203/10651MRI-00Siesta i TS Product Numbers: 866163/10653-00IntelliSave AX700 Product Numbers: 866205/10623-00Multiple Serial Numbers affectedARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd