NovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk
NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving risk of electrical shock and equipment malfunction from a grounding cable that can be inadvertently disconnected. No hospitalizations or illnesses have been reported. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
NovaGuide 2 Traditional Ultrasound systems (model REF: NSC-TCDNG2), manufactured by NovaSignal Corp., are subject to this recall due to a grounding cable issue. The systems may have grounding cables that can be inadvertently disconnected during normal use.
If the grounding cable becomes disconnected, the ultrasound system could experience electrical shock, electrical interference, and equipment malfunction. These hazards may affect both device operation and user safety.
A total of 28 affected systems have been distributed nationwide to medical facilities in Massachusetts, Texas, New York, Minnesota, Arizona, Alabama, Colorado, California, Ohio, Missouri, Florida, Tennessee, New Jersey, Georgia, Oklahoma, Kentucky, Washington, and Canada. Affected serial numbers are listed in the FDA recall notice.
If you own or operate one of these systems, contact NovaSignal Corp. immediately for inspection and remediation guidance.
The recalled product
- Product
- NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
- Manufacturer
- NovaSignal Corp.
- Affected units
- 28
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
Same manufacturer · NovaSignal Corp.
See all →- HighNovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk
FDA (Devices) · 2024-07-03
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Same hazard · electrical shock
See all →- High
- Severe
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