Despite withdrawal of the CE safety marking for Aquilon series of nebulisers, manufactured by AFP Medical, the nebulisers have still been placed on the market. A number of devices may have been sold despite the withdrawal of the CE marking, which means the safety of the product cannot be guaranteed.
CE safety certification is vital for consumer and supplier confidence in a product, and when it comes to medical products, such approval – or withdrawal, as is the case here – can be even more important.
Despite the withdrawal of the CE mark, the nebulisers and packaging still have the CE mark on them, but it has not been obtained through appropriate regulatory means. The devices are being withdrawn via several NHS Trusts throughout the UK, with any staff involved in the use and maintenance of the devices to take action.
- Aquilon2
- Aquilon
- Aquilon+
- Aquilon Pro series, manufactured since 01 April 2015
The importance of appropriate CE marking
CE safety certification is important, especially in the medical device industry. It’s important that products are properly regulated, and we have seen in the past what happens when medical products are not properly regulated.
The PIP Breast Implant scandal is a classic example. They were given the CE safety certification under false pretences because the PIP company deceived the safety regulator, TÜV Rheinland. We’re acting for many women pursuing claims against TÜV whose cases in the UK either failed due to clinics going bust, or were unable to settle claims in time.
In this scandal, thousands of women worldwide were told to have further surgery for their implants to be exchanged. Many women suffered huge complications because of the need for additional surgery and because of implants rupturing.