CLASS II ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report

NovaGuide 2 Traditional Ultrasound recalled by NovaSignal

NovaSignal is recalling NovaGuide 2 Traditional Ultrasound, distributed nationwide in the US. The recall was initiated on 6 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled28 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2217-2024
FDA event ID: 94673
Recalling firm: NovaSignal, Los Angeles, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 May 2024
FDA classified: 27 Jun 2024
Reported: 3 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

6 May 2024	Recall initiated by company
27 Jun 2024	Classified by FDA	+52 days
3 Jul 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Florida Georgia Kentucky Massachusetts Minnesota Missouri New Jersey New York Ohio Oklahoma Tennessee Texas Washington

Questions about this recall

Is NovaGuide 2 Traditional Ultrasound recalled?

Yes. NovaSignal recalled NovaGuide 2 Traditional Ultrasound on 6 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2217-2024.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from NovaSignal

All 4

Reported	Class	Recall	Company	Reason	Where
3 Jul 2024Device	CLASS II	NovaGuide 2 Intelligent Ultrasound, REFs recalled by NovaSignal	NovaSignal	Device Malfunction	Nationwide
8 Feb 2023Device	CLASS II	Lucid TCD 0 System recalled by NovaSignal	NovaSignal	Other	Nationwide
8 Feb 2023Device	CLASS II	NovaGuide Intelligent Ultrasound System recalled by NovaSignal	NovaSignal	Other	Nationwide

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