FDA-Device2023-02-08Class II

Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

NovaSignal Corp.
Hazard

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.

Sold states
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Affected count
6
Manufactured in
2440 S Sepulveda Blvd, N/A, Los Angeles, CA, United States
Products
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1049-2023

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