Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Summary
The FDA issued a Class II for Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System by NovaSignal Corp.. Reason: Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will re.
Details
Source
Device Recall
External ID
Z-1049-2023
Action Date
2023-02-08
Status
Ongoing
Category
device
Product Description
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Lot/Code Info: UDI-DI/Serial Numbers: 00850681007221/ 21020003, 20080004, 20100004, 21080001, 20120001; 00850681007009/ 19090005
Quantity Affected: 6
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
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-16
Company
Los Angeles, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NovaSignal Corp. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NovaSignal Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NovaSignal Corp. have FDA actions?
NovaSignal Corp. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1049-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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