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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94673

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
NovaSignal Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-2216-2024
Recall number
Z-2216-2024
Initiated
May 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
NovaSignal Corp.
Quantity
45 systems

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 2 of 2

NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

Z-2217-2024
Recall number
Z-2217-2024
Initiated
May 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
NovaSignal Corp.
Quantity
28 systems

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.