Medical Device Alert for x-ray units
A Medical Device Alert has been issued to raise awareness of a potentially dangerous, illegal, handheld, dental x-ray machine.
The Medicines and Healthcare products Regulatory Agency (MHRA), who raised the alert, is concerned that the non-CE marked portable dental x-ray units may have migrated over to the animal sector, as they are available to buy on the internet.
Testing by the Health Protection Agency has revealed that Tianjie Dental Falcon devices risk high doses of radiation due to insufficient shielding. They also pose an electrical fire hazard as they are not earthed or fused for the UK mains supply.
MHRA is currently investigating the supply of the devices, after seizing 13 from a distributor.
The agency is also raising awareness among veterinary practices that all devices used should carry a C-E mark, and be much more expensive than the unapproved version that is selling for as little as £200.
"Approved dental x-ray equipment, which could be either static or handheld, usually costs far more in the range from £3,000 to £5,000," says MHRA.
Click here for more information about the Medical Device Alert.
If you have bought one of these machines, please contact MHRA on 020 3080 6701 or via email.
Defra has published guidance for the vet sector ahead of a proposed UK-EU Sanitary and Phytosanitary agreement.
