The Recall Desk
HighFDA (Devices)·Z-2217-2024·Announced 2024-07-03

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.

What this means for you

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.
Hazard
  • electrical-shock
  • electrical-interference
  • equipment-malfunction

Distribution

Distributed nationwide across the United States.