FDA Device recall Z-1326-2020
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain
- FDA Device
- Class III
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class III recall of TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain by Theralase, citing 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 ver….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1326-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Theralase |
| Distribution | US |
Product
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
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)
Identifiers
| code_info | Serial Numbers: 3275 to 3350 (inclusive) |
|---|
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-1326-2020%22
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