Recall Z-1050-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NovaSignal Corp.
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)
| Date | Feb 1, 2023 (initiated Dec 16, 2022) |
| Status | Open, Classified |
| 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. |
| 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 anchal@novasignal.com |
| Quantity | 4 |
| Distribution | US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL |
| FDA record | Open on fda.gov |