NovaSignal Corp. Recall 91467
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)
NovaSignal Corp. Recall 91467 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1050-2023 |
| Event ID | 91467 |
| Event 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) |
| Product Type | Devices |
| Distribution | US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL |
| Quantity | 4 |
| Recall 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. |
| Device Classification | 20230208 |
| Device Code Info | System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004) |
| Center Classification Date | 20230201 |
| Recall Initiation Date | 20221216 |
| Recalling Firm | NovaSignal Corp. |
| Initial Notification | Letter |
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