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Terminated

TLC-2000 Therapeutic Medical Laser System

FDA Recall Z-1266-2020 · Posted 2020-02-13

Recalling FirmTheralase Inc.
Recall StatusTerminated
Product CodeNHN
Date Initiated2019-09-26
Date Terminated2020-12-03
Product Quantity18 units

Reason for Recall

Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

Firm Action

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition).

Root Cause

Process control

Distribution Pattern

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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