CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
NovaGuide Intelligent Ultrasound System recalled by NovaSignal
NovaSignal is recalling NovaGuide Intelligent Ultrasound System, distributed nationwide in the US. The recall was initiated on 16 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1050-2023
- FDA event ID
- 91467
- Recalling firm
- NovaSignal, Los Angeles, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2022
- FDA classified
- 1 Feb 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 16 Dec 2022 | Recall initiated by company | |
| 1 Feb 2023 | Classified by FDA | +47 days |
| 8 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
Nationwide ArizonaCaliforniaIllinoisPennsylvaniaSouth CarolinaTexas
Questions about this recall
Why was it 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.
Which lots are affected?
System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)
Where was it sold?
US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lucid TCD 2.0 System recalled by NovaSignal | NovaSignal | Other | Nationwide |
More recalls from NovaSignal
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NovaGuide 2 Intelligent Ultrasound, REFs recalled by NovaSignal | NovaSignal | Device Malfunction | Nationwide |
| Device | CLASS II | NovaGuide 2 Traditional Ultrasound recalled by NovaSignal | NovaSignal | Device Malfunction | Nationwide |
| Device | CLASS II | Lucid TCD 2.0 System recalled by NovaSignal | NovaSignal | Other | Nationwide |
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