NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1.… recallZ-1050-2023 · NovaSignal Corp. · initiated Dec 16, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NovaSignal Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 12/16/22, recall notices were emailed to customers. Customers were told they would be contacted by the recalling firm to facilitate the proper disposition of affected devices. If an unexpected reboot occurs, the recalling firm recommends pausing the use of affected devices until unaffected devices arrive. Complete and return the customer response form. Customers with questions can contact Customer Operations at [email protected]
Recall details
- Recall number
- Z-1050-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 16, 2022
- Posted by the FDA
- Feb 1, 2023
- Recalling firm
- NovaSignal Corp.
- Quantity
- 4
- Product code
- IYN
- FDA submissions
- K160442, K180455
- Distribution
- US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Product description
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)
Code information (models, lots, serial numbers)
System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Lucid Transcranial Doppler Ultrasound System (Lucid TCD) NA-LUCM1Novasignal Corp. · Transducer, Ultrasonic, Diagnostic2 recalls0 reports
- NovaGuide™ Intelligent Ultrasound System 05-00019Novasignal Corp. · System, Imaging, Pulsed Doppler, Ultrasonic1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K160442, K180455 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Lucid Transcranial Doppler System M1Novasignal Corp. · Transducer, Ultrasonic, Diagnostic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91467).
- Z-1049-2023 · Open, ClassifiedLucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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