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FDA”召回的二未经同意的“医疗设备

Joan Trombetti, Writer | December 16, 2008
FDA Recalls
A Class 1 recall was issued by the FDA for two potentially dangerous unapproved medical devices manufactured by VIBE Technologies of Greeley, CO., and Nebion LLC of Los Angeles.

Claiming there is a probability that the use of the devices could cause adverse health consequences or death, Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health said that the recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices.

One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.

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The federal agency said VIBE Technologies marketed the Vibrational Integrated Bio-photonic Energizer, claiming it could treat cancer, infections and depression. Nebion, the FDA said, failed to obtain marketing approval or clearance for its HLX8 device, which the company said can treat cancer, migraines, arthritis and ruptured discs.

The FDA said neither company demonstrated their devices were safe and effective at curing or treating diseases as claimed.