Events

Recall of Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-00445-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00445-1
  • 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
    Due to a software defect the ultraview sl command module can in advertently reset. the reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. upon completion of the reset sequence, all alarm limits will be reset to their site-defined default values. critical alarms for ventricular fibrillation and asystole are always enabled after the reset. if invasive pressure is being monitored, labels will be reset to default values and the zero calibration will be lost. if non-invasive pressure is being monitored, the automatic measurement mode will be disabled.A separate failure mode can also occur where the spo2 menu keys become unresponsive and prevent user changes to spo2 operation and alarm settings. in this state, all alarm limits, alarm functions and parameter monitoring continue unaffected and all alarm limits other than spo2 can still be adjusted.
  • Action
    Medtel Pty Ltd will contact users to schedule a convenient time to correct all of the affected Ultraview SL Command Modules at no cost. This action has been closed-out on 11/08/2016.

Device

Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015
  • Model / Serial
    Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015Catalogue number: 91496ARTG number: 109585
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA