Reported Feb 8, 2023 · Ongoing

NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot,…

NovaSignal Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NovaSignal Corp. · 2440 S Sepulveda Blvd · Los Angeles, CA · 90064-1784

Is this the product you have?

  • NovaGuide Intelligent Ultrasound System
  • ModelNA-RBTSYS1. Comprised
  • of NovaBot Automated Headset (AKANeuralBot
  • ModelNA-RBT1) and Lucid TCD 2.0
  • Transcranial Doppler Ultrasound (ModelNA-LUCM1)
Lot codes and dates
  • System (Tablet)UDI-DI/ Serial Numbers00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)
Amount recalled
4

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.