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)
FDA Recall Z-1050-2023 · Posted 2023-02-01
Recalling FirmNovaSignal Corp.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2022-12-16
Product Quantity4
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.
Firm 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]
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.