Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
- Company
- Novasignal Corp.
- Recall Initiated
- December 16, 2022
- Posted
- February 1, 2023
- Recall Number
- Z-1049-2023
- Quantity
- 6
- Firm Location
- Los Angeles, CA
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.
Distribution
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Lot / Code Info
UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005
Root Cause
Nonconforming Material/Component
Action Taken
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