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Terminated

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

FDA Recall Z-1419-06 · Posted 2006-08-24

Recalling FirmBiocare Systems Inc.
Recall StatusTerminated
Product CodeILY
Date Initiated2006-06-14
Date Terminated2011-01-03
Product Quantity175 units

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

Firm Action

Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.

Root Cause

Other

Distribution Pattern

Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051816LUMIWAVE 1X4 INFRARED THERAPY DEVICEBiocare Systems, Inc. · 2005-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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