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FDA Investigating Sale of Handheld Dental X-Ray Units Online

Most of the dental injuries that I come across as an Atlanta dental malpractice lawyer occur as a result of the negligence of dental professionals like technicians and dentists. However, sometimes injuries can also occur due to defective or malfunctioning dental equipment. The Food and Drug Administration is currently investigating the illegal sale of handheld dental x-ray units on the Internet.

According to the agency, dental professionals must be aware that these handheld dental x-ray units that are available online, may be potentially unsafe. The agency is not only concerned that the devices may not be as effective as those that are purchased from a retailer, but also that these devices may expose patients to harmful effects. For instance, the handheld devices may expose patients to potentially harmful radiation.

According to the Food and Drug Administration the handheld x-ray units were sold online, and were shipped to American consumers. The agency wants patients as well as dental professionals to know that these devices have not been approved by the Food and Drug Administration. The devices do not meet the agency’s radiation safety requirements.

There has been a lot of focus on radiation injuries recently. The New York Times has released a series of reports on radiation errors and injuries across the country. These involved a number of cases in which patients who received radiation therapy as part of their cancer treatment, were blasted with high doses of radiation due to improper operation of the machine. These patients suffered a range of injuries that, in some cases, even lead to death.

Dentists must take special care to make sure that the handheld dental x-ray unit that they use is approved by the Food and Drug Administration and meets the agency radiation safety standards. Many of the dental malpractice cases that I handle involve the mis-reading of radiographic results such as x-rays and 3-D cone beam CT scans (“CBCT”). While the handheld dental x-ray machines that are being purchased by general dentists on the internet to save money may be similar to those sold in-person by manufacturer reps and resellers, the critical difference lies in the implementation, set-up and training of users related to the machines. So, even if the machines are not defective, buying them on the internet without the benefit of proper support can cause user error which could lead to additional dental malpractice injuries and related lawsuits.

Attorney Robert J. Fleming has been handling wrongful death cases, automobile accident cases, personal injury cases, dental malpractice and medical malpractice lawsuits for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 20 years in and around Atlanta, Georgia and its surrounding areas, including Alpharetta, Austell, Avondale Estates, Chamblee, College Park, Conyers, Duluth, Decatur, Doraville, Hapeville, Johns Creek, Jonesboro, Lawrenceville, Norcross, Peachtree City, Riverdale, Roswell, Sandy Springs, Stone Mountain, and Smyrna. If you have been seriously injured and would like quality legal representation, contact Robert J. Fleming directly on (404) 525-5150 or contact us online.