FDA Device recall Z-1049-2023
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System by Novasignal, citing transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable sta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1049-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-16 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Novasignal |
| Distribution | US |
Product
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Reason
Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.
Identifiers
| code_info | UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1049-2023%22
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