FDA Announces Class I Recalls of Two Unapproved Devices

I had posted about the VIBE earlier this year. Both devices were not approved by the FDA. BD

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) ANNOUNCED A CLASS 1 RECALL TODAY FOR TWO UNAPPROVED AND UNCLEARED DEVICES WHOSE MANUFACTURERS CLAIMED COULD TREAT VARIOUS MEDICAL CONDITIONS. A CLASS 1 RECALL MEANS THAT THERE IS A REASONABLE PROBABILITY THAT THE USE OF A DEVICE WILL CAUSE ADVERSE HEALTH CONSEQUENCES OR DEATH.

THE MANUFACTURERS, VIBE TECHNOLOGIES OF GREELEY, COLO., AND NEBION LLC OF LOS ANGELES, CALIF., CLAIMED THEIR DEVICES TREATED CONDITIONS RANGING FROM CANCER TO MIGRAINES. THE FDA IS CONCERNED THAT BASED UPON THE ORIGINAL HEALTH CLAIMS MADE BY THE COMPANY, PATIENTS MAY FORGO APPROVED THERAPIES, AND THAT THIS COULD RESULT IN MORE SEVERE ILLNESS OR DEATH.

FDA Recalls VIBE Machine for Unproven Claims

VIBRATIONAL INTEGRATED BIO-PHOTONIC ENERGIZER DEVICE

ON APRIL 11, 2008, THE FDA ISSUED A WARNING LETTER TO VIBE TECHNOLOGIES STATING THAT THE AGENCY’S NOVEMBER 2007 INSPECTION OF THE FACILITY SHOWED THAT THE COMPANY HAD NOT OBTAINED FDA MARKETING APPROVAL OR CLEARANCE FOR THE VIBRATIONAL INTEGRATED BIO-PHOTONIC ENERGIZER (VIBE DEVICE), WHICH CLAIMS TO TREAT CANCER, INFECTIONS, AND DEPRESSION. THE FDA ALSO CITED THE COMPANY FOR SUBSTANTIAL DEVIATIONS FROM THE CURRENT GOOD MANUFACTURING PRACTICE/QUALITY SYSTEM REGULATION.

HLX8 DEVICE

IN JUNE 2008 FDA INSPECTED NEBION, LLC, WHICH REVEALED THAT THE COMPANY HAD NOT OBTAINED FDA MARKETING APPROVAL OR CLEARANCE FOR THE HLX8 DEVICE, WHICH CLAIMS TO TREAT CANCER, MIGRAINES, ARTHRITIS, AND RUPTURED DISCS. THE INSPECTION ALSO UNCOVERED SUBSTANTIAL DEVIATIONS FROM THE CURRENT GOOD MANUFACTURING PRACTICE/QUALITY SYSTEM REGULATION.

NEBION RECALLED EIGHT HLX8 DEVICES ON JULY 2, 2008, AND NOTIFIED THEIR CUSTOMERS TO STOP USING THE DEVICES IMMEDIATELY AND TO CONTACT NEBION FOR THEIR RETRIEVAL.