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.

Watch News 4 Now

Mouse over player for controls · LAUNCH FULL PLAYER

  • LocalMore>>

  • Downtown street flooded after wain main break Friday morning

    Downtown street flooded after wain main break Friday morning

    Friday, July 21 2017 6:46 AM EDT2017-07-21 10:46:19 GMT
    A water main break at 13th and Convention Plaza Friday morning (Credit: KMOV)A water main break at 13th and Convention Plaza Friday morning (Credit: KMOV)

    A water main break in downtown St. Louis caused flooding Friday morning.

    A water main break in downtown St. Louis caused flooding Friday morning.

  • DEVELOPING

    Suspect fatally shot by officers following chase in North City; another suspect on the run

    Suspect fatally shot by officers following chase in North City; another suspect on the run

    Friday, July 21 2017 6:08 AM EDT2017-07-21 10:08:16 GMT
    An officer-involved shooting happened in the 6100 block of Laura Thursday night. Credit: KMOVAn officer-involved shooting happened in the 6100 block of Laura Thursday night. Credit: KMOV

    Officers shot and killed a suspect in North City Thursday night, police said.

    Officers shot and killed a suspect in North City Thursday night, police said.

  • Man 'glad' to have been caught in police chase

    Thursday, July 20 2017 11:39 PM EDT2017-07-21 03:39:52 GMT
    Joseph Quinlan was caught in the middle of a police chase on Wednesday. (Credit: KMOV)Joseph Quinlan was caught in the middle of a police chase on Wednesday. (Credit: KMOV)

    A delivery man says it's a good thing he was caught up in the end of a police chase.

    A delivery man says it's a good thing he was caught up in the end of a police chase.

Powered by Frankly