Los Angeles, CA, United States
NovaSignal Corp. recalls
2 recalls recorded since 2018, most recently on 6 May 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 May 2024
- Reason
- Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, TX, NY, MN, AZ, AL, CO, CA, OH, MO, FL, TN, NJ, GA, OK, KY, WA and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2217-2024, Z-2216-2024
- NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
- NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Ongoing Class II Medical devices
- Recall started
- 16 December 2022
- 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.
- Distribution
- US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1050-2023, Z-1049-2023
- 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)
- Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.