NovaGuide Intelligent Ultrasound System — Class II medical device recall Z-1050-2023
Ongoing recall by NovaSignal Corp., reported 2023-02-08, distributed nationwide. Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze a
| Recall number | Z-1050-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NovaSignal Corp., Los Angeles, CA, United States |
| Recall initiated | 2022-12-16 |
| Classified | 2023-02-01 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| UPC / GTIN / UDI-DI | 00850681007221, 00850681007443 |
| Serial numbers | 00850681007443, 00850681007443/21021223, 22040001, 22040002 |
| Model numbers | NA-LUCM1, NA-RBT1, NA-RBTSYS1 |
Product
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
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.
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-1050-2023. 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.