The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2216-2024·Announced 2024-07-03

NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk

FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.

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 FDA Class II recall involves a risk-of-harm product (electrical shock hazard from a defective grounding cable) with no reported injuries, illnesses, or hospitalizations. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

NovaSignal Corp. is recalling 45 NovaGuide 2 Intelligent Ultrasound systems distributed across the United States and Canada. The affected models are NSC-NVGSYS2 (U.S. devices) and NSC-NVGSYS2-CA (Canadian devices), distributed to facilities in 17 U.S. states (Massachusetts, Texas, New York, Minnesota, Arizona, Alabama, Colorado, California, Ohio, Missouri, Florida, Tennessee, New Jersey, Georgia, Oklahoma, Kentucky, and Washington).

The recall addresses a manufacturing defect in which the grounding cable of the ultrasound system could inadvertently disconnect during use or handling. When the grounding cable becomes disconnected, it creates three hazards: electrical shock to users or patients, electrical interference with normal system operation, and equipment malfunction.

Healthcare facilities operating these devices should immediately verify whether their equipment is affected by checking the serial numbers provided by the FDA against their own devices. If an affected unit is identified, contact NovaSignal Corp. for instructions on repair, replacement, or other remedial actions.

The recalled product

Product
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Manufacturer
NovaSignal Corp.
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
45

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 (1)

  • UDI-DI: 00850681007399 (US devices)

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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 →

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