Radiation Danger Alert for Handheld Dental X-Ray Machines From Zhengzhou Tianjie Electronic Equipment Co.
12/4/2012 9:56:23 AM
Dentists are being warned to stop using portable X-ray machines that fail to display European conformity marks after one product was found to pose a health risk to patients. Tests carried out by the Health Protection Agency (HPA) and King's College Hospital found that the Tianjie Dental Falcon device lacks sufficient shielding in the X-ray tube, which could result in patients receiving unacceptable levels of radiation. It would also pose a risk to operators under typical dental surgery workloads. At least one dental surgery has been found using the device. The cheap imported machine has been available for sale on eBay. "We have seized 13 of these X-ray machines from the distributor but we urge anyone who has bought one of these machines to contact us," says Bruce Petrie of the Medicines and Healthcare products Regulatory Agency (MHRA) in a statement. The MHRA says the machine is not stamped with the mandatory CE mark as a medical device. The potential dangers from the Tianjie Dental Falcon device came to light after the HPA became aware that the cheap sets were for sale on the internet. Its Dental X-ray Protection Services team bought and tested one. They found there was insufficient lead shielding to protect dentists and patients from excessive radiation, that the X-ray beam was too wide and there was an unusually long X-ray exposure.