The federal watchdog said it knows of “at least 2” Multidata medical devices that the company manufactures and distributes in the U.S. without appropriate clearance or review.
The agency warned about issues with the Real Time Dosimetry Waterphantom System, and the Dual Channel Electrometer, both accessories to radiation therapy devices.
The FDA said that Multidata has been under a Consent Decree of Permanent Injunction with the U.S. District Court for the Eastern District of Missouri since 2003. The decree prohibits the company from designing, manufacturing, processing or distributing medical devices.
“The FDA has learned, however, that Multidata manufactured and distributed medical devices in violation of the Decree, including repairing and exchanging Waterphantom devices for newer design models,” the agency wrote in its warning.
Health care providers may be unaware of risks associated with the devices, the FDA warned, and urged facilities to discontinue use of any devices manufactured by Multidata.
The FDA said it is “not aware of adverse event reports associated with use of Multidata’s devices,” but warned that because it has not reviewed any 510(k) materials from the company it is “concerned about the potential risk to patients from the devices.”
Customers with such devices were advised to discontinue use with the Multidata equipment and only utilize FDA cleared devices.
The federal watchdog sent a letter demanding a halt to any designing, manufacturing, processing, packing, repacking, labeling, installing, holding for sale or distribution of any medical devices from Multidata.
The agency said it will “keep the public informed if significant new information becomes available.”