FDA Medical Device Recalls (openFDA)
VIBE Technologies: Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
- Recall number
- Z-0201-2009
- Recalling firm
- VIBE Technologies
- Product
- Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
- Status
- Terminated
- Initiated
- 2008-10-01
- Posted
- 2008-11-03
- Terminated
- 2012-05-21
- Reason
- Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
- Root cause
- PMA
- Action
- 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.
- Quantity
- 851 units
- Distribution
- Worldwide
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3004494240
- Firm city
- Greeley
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28