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Recall Observatory FDA recall evidence

Device product

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

Z-1049-2023

December 16, 2022

Class II

Product summary

Firm
NovaSignal Corp.
Event
Event 91467
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-1049-2023

Official wording

Reason: 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.

Code information: UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.