UK recalls falsely CE-marked personal Doppler foetal monitor
This article was originally published in Clinica
Executive Summary
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a public alert to discontinue the use and sale of an unapproved personal foetal monitor, pending further quality and safety assessments. The Baby Beets Fetal Doppler, made by a "legitimate manufacturer of foetal monitors" and marketed across the European Community by Lloyds Pharmacy, is not CE-marked (as required by a class 2a device), contrary to the product's packaging and marketing material, says the MHRA. The agency had seized at least 113 devices, according to its January 24 alert.
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