FDA Medical Device Recalls (openFDA)
VIBE Technologies: QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity.
- Recall number
- Z-0582-2009
- Recalling firm
- VIBE Technologies
- Product
- QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity.
- Status
- Terminated
- Initiated
- 2008-10-01
- Posted
- 2009-01-14
- Terminated
- 2012-05-03
- Reason
- Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
- Root cause
- PMA
- Action
- Customers were notified by letter on September 16, 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; and 3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides. Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.
- Quantity
- 58
- Distribution
- Worldwide Distribution.
- 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