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Terminated

TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

FDA Recall Z-1348-2020 · Posted 2020-02-13

Recalling FirmTheralase Inc.
Recall StatusTerminated
Product CodeNHN
Date Initiated2019-09-26
Date Terminated2020-12-03
Product Quantity202 units

Reason for Recall

Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards

Firm Action

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..

Root Cause

Process control

Distribution Pattern

U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Official Source

View FDA Recall →

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

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