2008年10月4日 星期六

Nebion HLX-8 一級回收

(http://bme.freebbs.tw 醫學工程論壇同步發表)
 
國內好像沒進,衛生署上也沒登記,有的話就是自己帶進的水貨,要多注意。
Nebion HLX-8 一級回收
http://www.fda.gov/medwatch/safety/2008/safety08.htm

Nebion HLX-8 Magnetic Resonance Device
Audience: Healthcare professionals, consumers
[Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[October 03, 2008 - Recall Notice - FDA]  

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