FDA recall Z-2216-2024

NovaSignal Corp. · Class II · device

Product

NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

Reason for recall

Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

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.

Key facts

Status
Ongoing
Initiation date
2024-05-06
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2216-2024