According to the agency, the company manufactured and distributed at least two radiation therapy devices — the Real Time Dosimetry Waterphantom System and the Dual Channel Electrometer — in the U.S. without gaining FDA clearance. Multidata Systems also failed to register their devices with the agency, which is required by federal law.
The FDA expressed concerns over healthcare providers not knowing the risks associated with these devices. It is not known how many of Multidata’s devices are currently use in hospitals throughout the country.
Clinicians should discontinue use of any Multidata device immediately and report any adverse events related to the devices to the FDA, according to the report.
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