Medical device recalls Moderate risk

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

Recall date
December 16, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1049-2023
FDA classification
Class II
Brand / firm
NovaSignal Corp.
Sold / distributed
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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