In a letter posted October 20, the U.S. Food and Drug Administration (FDA) urged healthcare providers to discontinue use of radiation therapy (RT) devices manufactured and sold by Multidata Systems International.
For at least two of the medical devices distributed in the U.S., the FDA never received or reviewed 510(k) applications. The devices are the company's Real Time Dosimetry Waterphantom system and its Dual Channel Electrometer.
The company was barred from designing, manufacturing, processing, and distributing medical devices in 2003, when it came under an injunction entered by the U.S. District Court for the Eastern District of Missouri. The firm was linked to a series of cases in Panama in 2000 and 2001 in which patients undergoing radiation therapy were overexposed.
Earlier this year, the FDA learned that Multidata was in violation of this injunction, and on March 3 it ordered the firm to "cease designing, manufacturing, processing, packing, repacking, labeling, installing, holding for sale, and distributing any medical device." Multidata has now ended operations and will be dissolving, the FDA said. A note on the company's website says it has suspended daily operations "due to the passing of our founder and president."
The agency urged facilities to discontinue use of any devices manufactured by Multidata, dispose of them appropriately, and use accessories to radiation therapy devices and radiation treatment planning software that have been appropriately reviewed and cleared. In addition, facilities should report any adverse events related to Multidata devices via MedWatch, the agency's safety information and adverse event reporting program.
For further information, contact the FDA's Division of Industry and Consumer Education (DICE) at [email protected] or 800-638-2041.
