NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Mode
FDA device recall Z-1050-2023 · posted 2023-02-01 · Open, Classified
Recall details
- Recalling firm
- NovaSignal Corp.
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- IYN
- Quantity affected
- 4
- Distribution
- US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
- Date initiated
- 2022-12-16
- Date posted
- 2023-02-01
- Location
- Los Angeles, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NeuralBot (K180455) | Neural Analytics, Inc. | 2018-05-22 |
| Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers (K160442) | Neural Analytics, Inc. | 2016-10-21 |