FDA Device recall Z-1348-2020
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- FDA Device
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 by Theralase, citing 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 editio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Theralase |
| Distribution | n/a |
Product
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Reason
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
Identifiers
| code_info | Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclus…Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334 |
|---|
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-1348-2020%22
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