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U.S. Department of Health and Human Services

Class 2 Device Recall NovaGuide Intelligent Ultrasound System

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  Class 2 Device Recall NovaGuide Intelligent Ultrasound System see related information
Date Initiated by Firm December 16, 2022
Date Posted February 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1050-2023
Recall Event ID 91467
510(K)Number K180455  K160442  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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)
Code Information System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)
Recalling Firm/
Manufacturer		 NovaSignal Corp.
2440 S Sepulveda Blvd
Los Angeles CA 90064-1784
For Additional Information Contact
424-367-8081
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 anchal@novasignal.com
Quantity in Commerce 4
Distribution US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = NEURAL ANALYTICS, INC.
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