Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
FDA Recall #Z-1049-2023 — Class II — December 16, 2022
Product Description
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
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.
Recalling Firm
NovaSignal Corp. — Los Angeles, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6
Distribution
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Code Information
UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated