Recall Z-1049-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NovaSignal Corp.
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
| 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 | 6 |
| Distribution | US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160442 | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers Neural Analytics, Inc., Oct 21, 2016 |