Events

Recall of Volumed VP7000 Premium, Volumed VP7000 Classic Plus, Syramed SP6000 Premium and Syramed SP6000 Classic Plus

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medevco 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-2013-RN-01054-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01054-1
  • 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
    Medevco identified that in some rare cases the key input line can trigger random key presses. even though the pumps correctly display the actual settings such as rate and volume infused at all times, random key presses can lead to alarms or undesired manipulations of the set values.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Action
    Allied Medical is providing users with a software update to permanently correct the issue.

Device

Volumed VP7000 Premium, Volumed VP7000 Classic Plus, Syramed SP6000 Premium and Syramed SP6000 Cl...
  • Model / Serial
    Volumed VP7000 Premium, Volumed VP7000 Classic Plus, Syramed SP6000 Premium and Syramed SP6000 Classic PlusARTG Number: 174698, 174697
  • Manufacturer
    Medevco Pty Ltd

Manufacturer

Medevco Pty Ltd
  • Source
    DHTGA