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Recall Observatory FDA recall evidence

Device product

NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

Z-2216-2024

May 06, 2024

Class II

Product summary

Firm
NovaSignal Corp.
Event
Event 94673
Status
Ongoing
Classification
Class II
Quantity
45 systems
Official record key
device-enforcement:Z-2216-2024

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-DI: 00850681007399 (US devices), 00850681007481(Canadian devices)/Serial Numbers: 22123240 22033466 22023447 21041633 21122796 22043986 23053678 23033627 22123241 21102756 21102757 21091951 21122798 21041632 22064209 23033624 23033625 22064212 22064207 22064210 21081932 22064208 21041631 21051651 22113121 21102759 21081931 21081933 21122801 21091952 23063852 22113120 22113122 23053679 22113119 23053681 21102760 21122799 22103019 22113113 23063830 23023429 23023421 23063829 22123270

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.