Dutch GGT Holding does not have a valid certificate and must now pull the 336 aeds back.
336 aeds should be withdrawn from the Danish market, because the manufacturer has not had a valid certificate.
this was stated by The Danish medicines agency on its website.
It is aeds of the brand Telefunken, which is pressed back. It is the Dutch company GGT Holding, who sold them.
the Reason is that the Dutch authorities have made the board aware that GGT Holding not have had a valid certificate for more than three years.
Hjertestarterne has wrongly been marked with the Sahabet CE. It validates that they comply with the EU legislation.
Why are aeds sold after 18. July 2016, withdrawn.
the Danish medicines agency has not found any indication that there would be errors or defects in the 336 aeds, which will be withdrawn.
There is a total of about 30,000 publicly accessible aeds in Denmark.
Aeds used in connection with cardiac arrest. They can measure the heart rhythm and send an electric shock if is needed to restart the heart rhythm.
Many other aeds on the market according to the Danish medicines agency be able to replace those that are withdrawn.
GGT Holding have been asked to contact the organizations, enterprises, institutions and individuals who have purchased aeds at the company.
at the same time, encouraged customers to contact their dealer to deliver hjertestarterne back.
/ritzau/Date Of Update: 25 November 2019, 14:00