NovaGuide 2 Ultrasound (NovaSignal) – Electrical Shock Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Brand
NovaSignal Corp.
Lot Codes / Batch Numbers
UDI-DI: 00850681007399 (US devices)
Products Sold
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
NovaSignal Corp. is recalling NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA 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