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Open, Classified

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

FDA Recall Z-1049-2023 · Posted 2023-02-01

Recalling FirmNovaSignal Corp.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2022-12-16
Product Quantity6

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.

Firm Action

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 [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc. · 2016-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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