FDA Device recall Z-1266-2020
TLC-2000 Therapeutic Medical Laser System
- 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 by Theralase, citing laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1266-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Theralase |
| Distribution | n/a |
Product
TLC-2000 Therapeutic Medical Laser System
Reason
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Identifiers
| code_info | Serial Numbers: 3333 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-1266-2020%22
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