Z-1049-2023 Class II Ongoing
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
- 6
Product Description
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
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
UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005