Recall Z-1050-2023— NovaSignal Corp.
Class II · Ongoing
Class II FDA medical device recall by NovaSignal Corp., initiated 2022-12-16. It names 2 FDA 510(k) clearances: K180455, K160442. 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). 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..
- Recalling firm
- NovaSignal Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-16
- Firm location
- Los Angeles, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K180455 — NeuralBot
- K160442 — Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.