Skip to content
Recall Observatory FDA recall evidence

Device product

NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

Z-2217-2024

May 06, 2024

Class II

Product summary

Firm
NovaSignal Corp.
Event
Event 94673
Status
Ongoing
Classification
Class II
Quantity
28 systems
Official record key
device-enforcement:Z-2217-2024

Official wording

Reason: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

Code information: UDI: 00850681007405/Serial Numbers: 21092746 21122802 21122803 21092748 21092749 21122804 21123066 23063826 22074381 23063828 22033706 22064206 22074380 21092747 22113115 23063825 21122805 21082646 23063856 23104174 21123068 22103022 22064204 22064205 21123067 22074378 22074379 23033578

Distribution pattern: Worldwide - US Nationwide distribution in the states of MA, TX, NY, MN, AZ, AL, CO, CA, OH, MO, FL, TN, NJ, GA, OK, KY, WA and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.