Events

Field Safety Notices about Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Invacare Ireland Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2011(25)
  • Date
    2011-11-11
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/storm3-range-(including-storm3-tt)-typhoon-i-typhoon-ii-power-wheelchairs&id=f281f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Invacare issued a field safety notice informing their customers of an update to transportation information provided in the user manual for the storm3 and typhoon range power wheelchairs. users of storm3 and typhoon range power wheelchairs should read the attached invacare field safety notice to determine if this information may have an impact on their transportation requirements.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have affected power wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Device

Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs
  • Model / Serial
  • Product Description
    Storm3 Range (including Storm3 TT), Typhoon I & Typhoon II Power Wheelchairs
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited