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Recall Observatory FDA recall evidence

Device product

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Z-0606-2020

September 26, 2019

Class III

Product summary

Firm
Theralase Inc.
Event
Event 84168
Status
Terminated
Classification
Class III
Quantity
41 units
Official record key
device-enforcement:Z-0606-2020

Official wording

Reason: Device was shipped without a Unique Device Identification (UDI) label.

Code information: Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device was shipped without a Unique Device Identification (UDI) label.