TLC-2000 Therapeutic Medical Laser System — Class III medical device recall Z-1266-2020
Terminated recall by Theralase Inc., reported 2020-02-26. Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edit
| Recall number | Z-1266-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theralase Inc., East York, Canada |
| Recall initiated | 2019-09-26 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-12-03 |
| Countries outside the US | AU, BH, CA, CN, HK, JO, MX, PH, PK, RO, TH |
| Quantity | 18 units |
| Serial numbers | 3333, 3350 |
Product
TLC-2000 Therapeutic Medical Laser System
Reason for recall
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1266-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.