# FDA recall Z-1049-2023

> **NovaSignal Corp.** · Class II · device recall initiated 2022-12-16.

## Product

Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

## Reason for recall

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.

## Distribution

US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL

## Key facts

- **Recall number:** Z-1049-2023
- **Recalling firm:** NovaSignal Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-16
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Los Angeles, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1049-2023

## Citation

> AI Analytics. FDA recall Z-1049-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1049-2023. Source: US FDA. Licensed CC0.

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