Home / Recalls / NovaSignal Corp. / Z-1050-2023

Z-1050-2023 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: 4

Product Description

NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)

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

System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)