Hearth Record

Vivid q ultrasound

Medical device recall Z-0757-2023. Published in FDA’s Enforcement Report on Dec 28, 2022.

FDA’s own record, on accessdata.fda.gov

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 Dec 28, 2022. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

2,609 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Model Number (System ID): H45021WZ (VQ20056, VQ20718, VQ020015, VQ20399, VQ202400, VQ20127, VQ20529, VQ20505, VQ20502, VQ20533, VQ20741, VQ20683, VQ20653, VQ20700, VQ20580, VQ20477, VQ20498, VQ020516, VQ020216, VQ20507, VQ20772, VQ20686,…

Every code shown here, 1,996 characters

Model Number (System ID): H45021WZ (VQ20056, VQ20718, VQ020015, VQ20399, VQ202400, VQ20127, VQ20529, VQ20505, VQ20502, VQ20533, VQ20741, VQ20683, VQ20653, VQ20700, VQ20580, VQ20477, VQ20498, VQ020516, VQ020216, VQ20507, VQ20772, VQ20686, VQ20043, VQ20508, VQ20566, VQ20620, VQ20525, VQ20483, VQ20601, VQ20706, VQ20591, VQ20122, VQ20668, VQ020275, VQ20713, VQ20198, VQ20863, VQ20052, VQ20597, VQ20619, VQ20614, VQ020676, VQ20154, VQ20584, VQ20599, VQ20204, VQ20429, VQ20284, VQ20045, VQ20568, VQ20562, VQ020662, VQ20524, VQ20730, VQ20628, VQ20287, VQ20266, VQ20569, VQ20110, VQ20116, VQ20109, VQ20560, VQ20671, VQ20278, VQR20075, VQ20504, VQ20607, VQ20007, VQ20054, VQ20611, VQR020000, VQ20910, VQ20133, VQ20108, VQ20415, VQ20469, VQ20367, VQ20341, VQ20051, 516663VIVIDQ, VQ20755, VQ30010LO, VQ20715, VQ020732, VQ020745, VQ20585, VQ20288, VQ20412, VI002091, VQ20712, VQ20702, VQ20464, VQ20417, VQ20638, VQ20722, VQ20747, VQ20593, VQ20456, VQ20326, VQ20181, VQ20773, VQ20522, VQ20081, VQ20521, VQR20082, VQ20673, VQ20519, VQ20018, VQ020749, VQ20571, VQ020577, VQ20654, VQ20735, VQ20074, VIQ622774CART, VQ20458, VQ20841, VQ20867, VQ20828, VQ003479, VQ20721, VQ20067, VQ20436, VQ20512, VQ20493, VQ20497, VQ20592, VQ20501, VQ20587, VQ020587, VQ20265, VQ20743, 0911365659, 0911365660, 0911365688, 0911367268, 0911363889, 0911365759, 0911369227, 0911363789, 0911363467, 0911367212, 0911367113, 0911367322, 0911365546, 0911365614, 0911365651, 0911365542, 0911365630, 030081US02, 030232US13, 784271US01, 390733US02, VQ50837VQ, VQ50249VQ, VQ50826VQ, VQ20908VQ, VQ50977VQ, VQ20949VQ, VQ20890VQ, 705792VQ1, 905455VIVQ, 403261VQ1, 403944VQ1, 403719VQ1, 905856VQ1, 514861VQ1, 506739VQ1, 905527VIVQ1, 905521VQ2, 905521VQ1, 250807VQ1, 519740VQ5, 519740VQ4, 519740VQ3, 519740VQ6, 519740VQ1, 519740VQ2, 905472VQ1, 705743VQ3, 705743VQ4, 705743VQ5, 705743VQ2, 604907VQ2, 647938VQ1, 902436VQ1, 416245VQ, 519250VQ1, 519250VQ2, 519250VQ3, VQ050222VQ, VQ30048VQ, VQ30313VQ, VQ50292VQ, VQ30305VQ, VQ020947VQ, VQ050288VQ,…

FDA’s list runs to 28,682 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D’Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.

The states and territories these words name

52 states and territories.

Every one of them
  • Alaska
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Delaware
  • Florida
  • Georgia
  • Guam
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • US Virgin Islands
  • Vermont
  • Washington
  • Wisconsin
  • West Virginia

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Nov 10, 2022.
  • FDA classified it on Dec 22, 2022.
  • FDA’s Enforcement Report published it on Dec 28, 2022.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • GE Medical Systems, LLC, of Waukesha, WI.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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.”
  • FDA’s list of codes runs to 28,682 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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