FDA warns radiation technology could put patients' health at ris - KFVS12 News & Weather Cape Girardeau, Carbondale, Poplar Bluff

FDA warns radiation technology could put patients' health at risk

Medical devices by Multidate Systems International Corporation (Credit: Multidate Systems International Corporation) Medical devices by Multidate Systems International Corporation (Credit: Multidate Systems International Corporation)
ST. LOUIS, Mo. (KMOV.com) -

The U.S. Food and Drug Administration sent out a safety alert to hospitals across the country that patients’ health might be at risk.              

Multidata Systems International Corporation, A St. Louis-based medical supply company, sold two radiation therapy devices without getting federal approval.               

The FDA said it doesn't know how many of these devices are out there, so it is asking hospitals and clinics nationwide to discontinue the use of the devices.

Locally, News 4 found out 11 BJC hospitals do not use them. SLU Hospital also confirmed it doesn’t use the devices.            

Multidata Systems manufactured and distributed Real Time Dosimetry (RTD) Waterphantom System and the Dual Channel Electrometer across the country without clearance, according to the FDA.  

The FDA said since 2003, Multidata Systems has been under a Consent Decree of Permanent Injunction by the U.S. District Court for the Eastern District of Missouri. The decree prohibits the company from designing, making, processing, or distributing medical devices of any kind, along with other stipulations.  

However, recently the federal agency found the company did not to register their devices as required by federal law.

So far, the FDA is not aware of any reported injuries, however it said the injuries could range anywhere between mild to severe. The FDA found there is the potential for patients to get too much or too little radiation during treatments. 

News 4 reached out to Multidata, but didn't hear back. An online search for the medical supply company showed it's permanently closed.

"Due to the passing of our founder and President, Multidata is closed at this time," the website read.

Copyright 2016 KMOV (Meredith Corporation). All rights reserved.

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