Z-1419-06

LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc

Name: Z-1419-06 LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc
Creator: Biocare Systems Inc.
Published: 2006-06-14
License: https://open.fda.gov/license/

Biocare Systems, Inc. / initiated 2006-06-14 / Terminated

FDA source

Biocare Systems Inc. began a recall of LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc on 2006-06-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1419-06
Status: Terminated
Initiated: 2006-06-14
Posted: 2006-08-24
Terminated: 2011-01-03
Recalling firm: Biocare Systems, Inc.
Product: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
Product code: ILY Lamp, Infrared, Therapeutic Heating
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
FDA root cause: Other
Action: Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.
Quantity in commerce: 175 units
Distribution: Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.
Product codes and lots: Catalog # LW1X4, all units, all lots

Product code ILY

K051816Class IILumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc. / cleared 2005-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)