NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Recall
- Recall Number
- Z-2217-2024
- Event Number
- 94673
- Firm
- NovaSignal Corp.
- FEI Number
- 3013368530
- Product Code
- IYN
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 6, 2024
- Posted
- June 27, 2024
- Address
- 2440 S Sepulveda Blvd, Los Angeles, CA, 90064-1784
Description
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
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.
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.
28 systems