Recall Z-2216-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NovaSignal Corp.
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
| Date | Jun 27, 2024 (initiated May 6, 2024) |
| Status | Open, Classified |
| Reason | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. |
| 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 |
| Quantity | 45 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213279 | NovaGuide 2 Intelligent Ultrasound Novasignal Corporation, Mar 2, 2022 |