The FDA issued a warning today that some hand-held X-ray units marketed toward dental health providers and veterinarians haven’t been cleared by the FDA and may pose risks to users and patients.
The Washington State Dept. of health altered the FDA after testing one of the devices, purchased online, and found that the device didn’t comply with X-ray performance standards.
"Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA’s standards," Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices & Radiological Health, said in prepared remarks.
The devices are manufactured outside the U.S. and shipped directly to customers, according to the FDA release.
No adverse events associated with the X-ray devices have been reported yet and the FDA is investigating the extent of the problem.
The agency warned health care providers to look for FDA labels on any X-ray devices and check the FDA’s device clearance database to ensure that they’re buying devices that have gone through the correct channels for the U.S. market.
The FDA plans to monitor the problem and keep state regulatory authorities abreast of findings. Any substantive information will also be forwarded to the agency’s Office of Criminal Investigations.
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