FDA Investigating Sale of Illegal Handheld Dental X-Ray Units

The federal Food and Drug Administration (FDA) is advising dental professionals to be wary of purchasing handheld dental X-ray units through e-commerce channels, citing an increasing number of illegal, unapproved devices for sale online.

The FDA has issued a statement warning these illegal handheld devices may be unsafe, ineffective, and could expose patients and staff to potentially harmful levels of radiation. The federal watchdog agency stated that unapproved devices manufactured overseas and shipped to the United States have not undergone FDA review, and may not meet radiation safety requirements or comply with federal X-ray performance standards.

The Washington State Department of Health first alerted the agency of a potential problem with illegal handheld dental X-ray devices being sold online, triggering an FDA investigation.

Officials caution health care professionals to ask potential vendors to provide proof of FDA approval of handheld radiography devices, to check existing units to see if they are tagged with required labels, and to verify the unit is listed on the FDA Medical Device Approvals and Clearances database. Clinicians should contact state regulatory agencies if a device does not meet these criteria.