Events

Field Safety Notices about Invacare Mobility Powerchairs Control Systems

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
    SN2012(02)
  • Date
    2012-03-21
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/invacare-mobility-powerchairs-control-systems&id=0180f825-9782-6eee-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 (fsn) highlighting to users of invacare mobility powerchairs that the integration of a replacement joystick or power module into a wheelchair or the reprogramming of the existing joystick or power module by someone other than invacare potentially carries a risk as the functionality and performance of the wheelchair may not conform with the specification as originally supplied.
  • Action
    The IMB advises that users ensure the appropriate personnel are made aware of this notice and follow the manufacturer’s recommendations in the attached field safety notice.

Device

Invacare Mobility Powerchairs Control Systems
  • Model / Serial
  • Product Description
    Invacare Mobility Powerchairs Control Systems
  • Manufacturer
    Invacare Ireland Limited

Manufacturer

Invacare Ireland Limited