FDA Medical Device Recalls (openFDA)
Biocare Systems Inc.: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
- Recall number
- Z-1419-06
- Recalling firm
- Biocare Systems Inc.
- Product
- LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
- Status
- Terminated
- Initiated
- 2006-06-14
- Posted
- 2006-08-24
- Terminated
- 2011-01-03
- Reason
- Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard
- Root cause
- Other
- Action
- Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.
- Quantity
- 175 units
- Distribution
- Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.
- Lot, serial or model codes
- Catalog # LW1X4, all units, all lots
- 510(k) numbers
- ["K051816"]
- PMA numbers
- not on file
- Product code
- ILY
- Firm FEI
- 3005510978
- Firm city
- Parker
- 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