Ultrasound system hard drive defect causes device freezing and failure
FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is equipment malfunction that renders the system inoperable.
Plain-English summary
The NovaGuide Intelligent Ultrasound System (Model NA-RBTSYS1), comprised of the NovaBot Automated Headset and Lucid TCD 2.0 Transcranial Doppler Ultrasound, is being recalled by NovaSignal Corp. due to a faulty hard drive in the system tablet.
The defect causes the tablet to freeze and reboot. Although the system initially restarts and operates normally, the faulty hard drive will eventually cause the system to become completely inoperable.
The recalled units have been distributed both nationwide and worldwide. Affected parties should contact NovaSignal Corp. for information regarding repair, replacement, or return of the recalled systems.
The recalled product
- 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)
- Manufacturer
- NovaSignal Corp.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001
- 00850681007443/ 22040002
- 00850681007443/21021223 (00850681007221/ 21090003)
- 00850681007443/ 22064227 (00850681007221/ 21090004)
Distribution
Part of a larger recall action
This product is one of 2 recalled by NovaSignal Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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