U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
원인
Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
조치
Vibe Technologies notified their customers by letter on October 1, 2008 and were told to discontinue use as a medical device. This letter notification included:
1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such.
2. An updated operation manual/users guide containing no medical conditions or human body claims.
3. A certification to be signed by the user and returned acknowledging that they: received the letter; affixed the warning label to the Vibe machine; understand that the Vibe machine does not affect the structure/function of the human or animal body; will not promote the Vibe machine as a medical device; will remove any medical claims from their website; destroy any Vibe literature making medical claims. Approximately three weeks after the certified mailing, the firm will begin performing recall effectiveness checks.