The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert concerning a number of Ibis comfort wheelchairs, delivered between 29 January and 12 April 2013, manufactured by Handicare B.V. The affected serial numbers are:
Handicare has discovered a potential quality issue with the tilt adjustment on a limited number of Ibis comfort wheelchairs. In extreme situations, a component used in the tilt mechanism may break, which could cause the seat unit to tip backwards.
According to Handicare, no injuries have been reported. Handicare has decided to replace all components from the affected batch as a precautionary measure. Users are requested to order a replacement set and exchange the upper hinge blocks (article no.: 02010.6182) used in the tilt mechanism on all affected wheelchairs they have.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON295475
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 July 2013