NovaGuide 2 Traditional Ultrasound (NovaSignal) – Electrical Shock Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Brand
NovaSignal Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
NovaSignal Corp. is recalling NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 due to Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment mal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026