LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
FDA device recall Z-1419-06 · posted 2006-08-24 · Terminated
Recall details
- Recalling firm
- Biocare Systems Inc.
- Reason for recall
- 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
- Action taken
- Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- ILY
- Quantity affected
- 175 units
- Distribution
- Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.
- Date initiated
- 2006-06-14
- Date posted
- 2006-08-24
- Date terminated
- 2011-01-03
- Location
- Parker, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMIWAVE 1X4 INFRARED THERAPY DEVICE (K051816) | Biocare Systems, Inc. | 2005-08-26 |