Z-1050-2023Class II

NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA...

Name: Z-1050-2023 NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA...
Creator: NovaSignal Corp.
Published: 2022-12-16
License: https://open.fda.gov/license/

NeuraSignal, Inc. / initiated 2022-12-16 / Open, Classified / root cause: manufacturing process

FDA source

NovaSignal Corp. began a recall of NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0... on 2022-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1050-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-16
Posted: 2023-02-01
Recalling firm: NeuraSignal, Inc.
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)
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]
Quantity in commerce: 4
Distribution: US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Product codes and lots: System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1050-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1049-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01
Z-1050-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)