FDAnews Device Daily Bulletin

Discontinue Use of Multidata Radiation Therapy Devices, FDA Says

Oct. 25, 2016

The FDA has issued a letter to radiology specialists that the agency is concerned that health care providers may be unaware of the risks associated with Multidata devices and urged facilities to discontinue the use of any devices manufactured by Multidata and dispose of them appropriately.

The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the U.S. for which the FDA never received nor reviewed 510(k) premarket notifications. These devices include accessories to radiation therapy devices, including the Real Time Dosimetry (RTD) Waterphantom System and the Dual Channel Electrometer.

Multidata has been subject to a permanent injunction since 2003 barring it from manufacturing or distributing medical devices, the FDA said.

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