Imtmedical ag, FSN-FSCA-2021-002, Diagnostic Package Pulse Oxymetry/Capnography

It has come to our attention that the CE mark with the Notified Body number (0124) of DEKRA Certification GmbH, was placed in error on the outer packaging of the two accessories for the bellavista family of ventilators listed above. Consequently, the products do not fulfill labelling compliance requirements, and therefore,  imtmedical ag is removing them from the market. There is neither impact to actual use of the product nor a product safety concern. This is an issue of labelling non-complaince.