Z-2217-2024Class II

NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

Name: Z-2217-2024 NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Creator: NovaSignal Corp.
Published: 2024-05-06
License: https://open.fda.gov/license/

NeuraSignal, Inc. / initiated 2024-05-06 / Open, Classified / root cause: design

FDA source

NovaSignal Corp. began a recall of NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 on 2024-05-06. FDA classified it as Class II and gives the reason as "Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2217-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-06
Posted: 2024-06-27
Recalling firm: NeuraSignal, Inc.
Product: NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
Root cause tag: design
FDA root cause: Device Design
Action: On May 6, 2024, NeuraSignal Inc. dba NovaSignal issued a "Urgent-Medical Device Recall" notification to affected consignees. Nova Signal asked consignees to take the following actions: 1. The NeuraSignal service and customer support team will schedule a time for the onsite field correction. 2. In the timeframe leading up to the scheduled onsite field correction, the system can be used as intended. 2a. Users of the device should refrain from accessing the enclosed cable connections during routine operation. This may lead to unintentional disconnection of the chassis ground cable from the AC mains power distribution unit. It is recommended that the cart compartment remains locked while the device is commissioned for use. 3. The site should confirm that the grounding cable has not been unintentionally disconnected and maintains a secure connection to the power distribution unit 4. If necessary, resources from the Biomedical Equipment department may perform re-qualification or pre-installation qualification testing, to ensure the system is adequately grounded.
Quantity in commerce: 28 systems
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2217-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2216-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27
Z-2217-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code IYN

K213279Class IINovaGuide 2 Intelligent UltrasoundNovasignal Corporation / cleared 2022-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)