FDA Device recall Z-0606-2020
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain
- FDA Device
- Class III
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class III recall of TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain by Theralase, citing device was shipped without a Unique Device Identification (UDI) label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0606-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Theralase |
| Distribution | US |
Product
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Reason
Device was shipped without a Unique Device Identification (UDI) label.
Identifiers
| code_info | Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0606-2020%22
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