FDA Device recall Z-1050-2023
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Luc…
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Luc… 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-1050-2023 |
| 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
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
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 | System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (008…System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004) |
|---|
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-1050-2023%22
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