NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Medical device recall Z-2216-2024. Published in FDA’s Enforcement Report on Jul 3, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 3, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 17 states named
- 45 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
45 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 490 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
17 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Florida
- Georgia
- Kentucky
- Massachusetts
- Minnesota
- Missouri
- New Jersey
- New York
- Ohio
- Oklahoma
- Tennessee
- Texas
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 6, 2024.
- FDA classified it on Jun 27, 2024.
- FDA’s Enforcement Report published it on Jul 3, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NovaSignal Corp., of Los Angeles, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.