The Spanish Agency for Medicines and Health Products (AEMPS), belonging to the Ministry of Health, has ordered the cessation of use of certain ‘Dolomite Gloss’ walkersmanufactured by Invacare, because the durability of your seat may be compromised.
The AEMPS has been made aware of this irregularity through the company Invacare Rea AB (Sweden), which has reported that the seats of certain models and serial numbers of the Invacare ‘Dolomite Gloss’ walkers do not work as expected when these are used intensively or are subjected to strong external impacts.
The walker is designed to provide support while walking and also as a rest seat for people with disabilities. deterioration of muscle strength and/or balance problems, needing additional support while walking.
The products affected by this irregularity and which, therefore, must stop being used are the models Gloss 450, Gloss 520, Gloss 600 y Gloss 680manufactured between February 2020 and October 2022 and with a serial number range of 20BHL0002 a 22J02000316.
According to the information provided by the manufacturer and although the different models of the Gloss walker meet fatigue and static load requirements In accordance with ISO 11199-2, it has been proven that the durability of the seat can be compromised and lead to premature breakage during use.