Z-1049-2023 Class II Ongoing

Recalled by NovaSignal Corp. — Los Angeles, CA

Recall Details

Product Type
Devices
Report Date
February 8, 2023
Initiation Date
December 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6

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.

Distribution Pattern

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