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​Medical Device Alert - Telefunken defibrillators

26 July 2019

 

The MHRA has issued a Medical Device Alert for all Telefunken HR1 & FA1 automated external defibrillators, as no valid CE certificate is in place.

 

The CE certificate for Telefunken defibrillators was suspended in July 2016 and subsequently withdrawn in April 2017. Without a valid CE certificate, a manufacturer may not place its devices on the market. However, in this case the manufacturer continued to sell them.

 

Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

 

If you discover you have one of these devices, you should take the following actions:

 

  • Immediately acquire an alternative defibrillator as these devices do not meet regulatory requirements for safety and performance.
  • Complete a local risk assessment for the continued use of the affected devices until an alternative device is sourced.
  • Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate. 

Contact details for enquiries relating to this alert and information on how to report incidences for each UK country are available at the end of the MHRA Alert.

 

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