TLC-2000 Therapeutic Medical Laser System Power Pack — Class III medical device recall Z-1348-2020
Terminated recall by Theralase Inc., reported 2020-03-04. Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd
| Recall number | Z-1348-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theralase Inc., East York, N/A, Canada |
| Recall initiated | 2019-09-26 |
| Classified | 2020-02-24 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-12-03 |
| Countries outside the US | AU, BH, CA, CN, HK, JO, MX, PH, PK, RO, TH |
| Quantity | 202 units |
| Serial numbers | 3104-3106 |
| Model numbers | TLC-2002 |
Product
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Reason for recall
Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
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-1348-2020. 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.