Certain hand-held dental X-ray units sold online by manufacturers outside of the United States could pose a radiation risk, according to the Food and Drug Administration.
The agency warned dental and veterinary professionals to not purchase or use hand-held dental X-ray devices without first verifying that the devices have been reviewed and tested to meet FDA standards. All units that have been cleared by the FDA bear a permanent certification label/tag, a warning label and an identification label/tag.
The Washington State Department of Health alerted the FDA after tests on a device purchased online revealed that it did not comply with X-ray performance standards. As a result, the FDA is investigating and notifying state regulatory authorities, dental professional organizations and other health organizations about the safety risks. No adverse events have been reported.
To ensure a device has been reviewed and tested by the FDA, the agency advised users to:
• Verify the device bears certification, warning and ID labels.
• Ask their vendor whether the device has been reviewed and cleared by the FDA.
• Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit has been reviewed by the FDA.
The agency said it will monitor the situation and will keep the public informed as new information becomes available.