Summary
The FDA issued a Class II for NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 by NovaSignal Corp.. Reason: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment mal.
Details
Source
Device Recall
External ID
Z-2217-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Lot/Code Info: 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
Quantity Affected: 28 systems
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-06
Company
Los Angeles, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NovaSignal Corp. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NovaSignal Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NovaSignal Corp. have FDA actions?
NovaSignal Corp. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2217-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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