Class 2 Device Recall LumiWave Infrared lamp

• Date Initiated by Firm: June 14, 2006
• Date Posted: August 24, 2006
• Recall Status: Terminated on January 03, 2011
• Recall Number: Z-1419-06
• Recall Event ID: 35780
• 510(K)Number: K051816
• Product Classification: Infrared lamp - Product Code ILY
• Product: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
• Code Information: Catalog # LW1X4, all units, all lots
• FEI Number: 3005510978
• Recalling Firm/ Manufacturer: Biocare Systems Inc.; 9853 Paperflower Drive; Parker CO 80138
• For Additional Information Contact: Ms. Lanaya Reiter; 303-796-7043
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ILY