Events

Recall of Mobile Shower and Toilet Commode Aquatec Ocean VIP

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Invacare 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-2014-RN-00518-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00518-1
  • 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 manufacturer has advised that during regular market observation they noticed that some of the snap-on fixtures do not withstand the required pull out force. this was caused due to an inconsistency of the injection moulding, and did not meet the design specification for the snap-on fixtures. the male portion of the clip has a 90-degree angle overhang; and this was not completely filled as per specification. the attachment mechanism has the potential to unintentionally open when the product is used in the recline position.
  • Action
    Invacare is requesting the device providers to locate all affected Mobile Shower and Toilet Commode Aquatec Ocean VIP and replace the faulty clips. Further information on this recall action can be found on the TGA website at http://www.tga.gov.au/safety/alerts-device-aquatec-ocean-vip-mobile-shower-toilet-commode-140522.htm . This action has been closed-out on 04/04/2017

Device

Mobile Shower and Toilet Commode Aquatec Ocean VIP
  • Model / Serial
    Mobile Shower and Toilet Commode Aquatec Ocean VIPMultiple serial numbers affectedARTG Number: 153914
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd