NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 recallZ-2217-2024 · NovaSignal Corp. · initiated May 6, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NovaSignal Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2217-2024
- Status
- Open, Classified
- Initiated by the company
- May 6, 2024
- Posted by the FDA
- Jun 27, 2024
- Recalling firm
- NovaSignal Corp.
- Quantity
- 28 systems
- Product code
- IYN
- FDA submissions
- K213279
- 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 description
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NovaGuide™ 2 Traditional Ultrasound System NSC-TCDNG2Novasignal Corp. · System, Imaging, Pulsed Doppler, Ultrasonic1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K213279 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NovaGuide™ 2 Intelligent Ultrasound System 05-00030Novasignal Corp. · System, Imaging, Pulsed Doppler, Ultrasonic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94673).
- Z-2216-2024 · Open, ClassifiedNovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page