United KingdomThe ORTONES Wheelchair and Geriatric Armchair Lap Belt (model D2100), an abdominal fabric lap/support belt sold via Amazon in the UK, is affected. It was withdrawn because it can shift and constrict the neck, presenting a risk of strangulation, positional asphyxiation, falling or injury; the manufacturer has issued an updated instruction manual and warns the belt should be used only under the supervision or prescription of a health professional, is not suitable for users without good body control, and to consult a health professional if there are respiratory or cardiac problems.
What's being recalled
Product Safety Report for ORTONES Wheelchair and Geriatric Armchair Lap Belt presenting a risk of strangulation.
Type: Lap/Support Belt for Wheelchair User
Brand: ORTONES
Model: D2100
Country of Origin: Unknown
Product Description: Abdominal fabric belt designed to provide support to users of a wheelchair, geriatric chair or armchair.
How to identify it
PSD notification number: 2510-0031
Notified by: Office for Product Safety and Standards
The hazard
The product presents a risk of strangulation. A vulnerable individual may slide downward in a wheelchair or armchair while restrained by the lap belt, causing the belt to shift and constrict the neck.
Without proper fitting, supervision or training, this can result in positional asphyxiation, strangulation, or falling from the seat and becoming injured, particularly if the user is unattended and/or unable to self-rescue.
The Medicines and Healthcare products Regulatory Agency (MHRA) previously issued an Alert for this type of product, which contains further information on actions that should be taken: Medical Device Alert
The product does not meet the requirements of the General Product Safety Regulations 2005.
What to do
The product has been withdrawn from the UK market by the manufacturer. An updated instruction manual has been issued to consumers, warning of the risks presented by the product.
Owners of the ORTONES belt are advised by the manufacturer to ensure that the belt should be used only under the supervision or prescription of a health professional or specialist technician. The manufacturer warns that the product is not suitable for users who do not have good body control when seated, and that a health care professional should be consulted before using the belt if the owner has respiratory or cardiac problems.
OPSS advises that owners of similar products ensure that they can be safely used in accordance with the manufacturer’s instructions, under the appropriate supervision and prescription of a health care professional.
The official notice
This page is a summary of the notice published by Office for Product Safety and Standards, collected from Office for Product Safety and Standards. Check the original before you act on it.
Read the official notice (opens in a new tab)