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Recall Observatory FDA recall evidence

Device product

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

Z-1326-2020

September 26, 2019

Class III

Product summary

Firm
Theralase Inc.
Event
Event 84845
Status
Terminated
Classification
Class III
Quantity
76 units
Official record key
device-enforcement:Z-1326-2020

Official wording

Reason: Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)

Code information: Serial Numbers: 3275 to 3350 (inclusive)

Distribution pattern: Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)