Events

Field Safety Notices about Action® 2000 Manual 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(28)
  • Date
    2011-11-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/action-2000-manual-wheelchairs&id=6581f825-9782-6eee-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
    In august 2007, invacare changed the method of mounting the castor assembly to the sideframe. the thread length on the bolts used to mount the castors were found to be insufficient to guarantee that the bolts can be correctly tightened. loose bolts could potentially cause the sudden failure of one or both of the castor housing bolts, and the possibility of a fall from the wheelchair which could result in injury to the user.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected wheelchairs.  3. If you / your institution have affected 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

Action® 2000 Manual Wheelchairs

Manufacturer

Invacare Ireland Limited