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# Stop Using Multidata Radiation Therapy Devices: FDA
- URL: https://www.fdaweb.com/stop-using-multidata-radiation-therapy-devices-fda/
- Published: 2016-10-20T12:00:00.000Z
- Updated: 2026-09-14T21:41:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137129

FDA says it is recommending that healthcare providers stop using Multidata Systems radiation therapy devices because they have not received 510(k) clearance from the agency. A [notice](http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htm?utm%5Fsource=dlvr.it&utm%5Fmedium=twitter) to radiation oncologists, medical physicists, dosimetrists, and radiation therapists says that for at least two of the company’s devices, the agency never received nor reviewed 510(k) premarket notifications. The devices were identified as accessories to radiation therapy devices including the Real Time Dosimetry Waterphantom System and the Dual Channel Electrometer. The company also has not registered or listed its devices with FDA as required by law, the notice says.

Multidata has been under a consent decree of permanent injunction since 2003, FDA says, and is prohibited from designing, manufacturing, processing, and distributing medical devices, among other restrictions. But the agency says it has learned that the company manufactured and distributed medical devices in violation of the decree, including repairing and exchanging Waterphantom devices for newer models.

“FDA is concerned that healthcare providers may be unaware of the risks associated with these devices and urges facilities to discontinue the 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 reviewed and cleared by FDA,” the notice says. The agency says it is not aware of adverse event reports associated with using Multidata devices since the decree took effect, but it is concerned about the potential risk to patients from the devices since it has not received or reviewed 510(k) premarket notifications. It says that after receiving a 3/3 letter from FDA, the company permanently ceased operations and is dissolving.