Unapproved Medical Devices Subject to Class I RecallDec 16, 2008 | Parker Waichman LLP
Federal regulators have announced a Class I recall of two unapproved medical devices. The recall involves Vibrational Integrated Bio-photonic Energizer (VIBE device) sold by VIBE Technologies of Greeley, CO and the HLX8 device marketed by Nebion LLC of Los Angeles, Calif. According to the agency's recall notice, neither VIBE Technologies nor Nebion has demonstrated to the FDA that these devices are safe and effective at curing or treating diseases as claimed.
A Class I recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death. According to the FDA, VIBE and Nebion both claimed their devices treated conditions ranging from cancer to migraines. The agency 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.
The FDA said it is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, the FDA said it has not verified that there is any association between the death and the VIBE device.
"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said in a press release announcing the recalls. "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.”
On its website, Vibe Technologies claimed that the VIBE Machine ” increases your inner-connectively to your DNA, giving it what it needs to balance itself. This machine is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level".
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 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.
VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.
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, the FDA said. The recall followed a June 2008 FDA inspection of the company which revealed that Nebion 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's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.