GGT Holding, V2005362, Telefunken/HeartReset

Inspectorate’s rectification
On 27 June 2019, the Health and Youth Care Inspectorate (IGJ) advised users to replace the Telefunken and HeartReset AEDs manufactured from 18 July 2016 ( https://www.igj.nl/actueel/nieuws/2019/06/27/aed%E2%80%99s-zonder-geldig-ce-certificaat-op-de-markt). The reason is that these AEDs do not have a valid CE certificate.
After this, GGT Holding B.V. sent out a field safety notice (FSN) to its customers about these AEDs. This FSN contains incorrect information. The IGJ wishes to inform users of the most important discrepancies. Firstly, the FSN wrongly implies that it was a notified body that falsified the CE certificate. Secondly, while the manufacturer currently consults a notified body about certification of its AEDs, the IGJ emphasises that when a new CE certificate is issued, the AEDs without a valid CE certificate will not automatically be covered under this certificate.