5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500…
Medical device recall Z-1757-2024. Published in FDA’s Enforcement Report on May 15, 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 May 15, 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 26 states named
- 363 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?
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
363, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Compact 5000 series systems manufactured on or before 20-Dec-2023 and purchased with Deluxe and Premium Cart options. REF/UDI-DI/Serial Numbers: 505500 CV/795141/00884838116566/USN23P0684, USN23P0623, USN23P0624, USN23P0685,…
Every code shown here, 1,998 characters
All Compact 5000 series systems manufactured on or before 20-Dec-2023 and purchased with Deluxe and Premium Cart options. REF/UDI-DI/Serial Numbers: 505500 CV/795141/00884838116566/USN23P0684, USN23P0623, USN23P0624, USN23P0685, USN23P0720, USN23P0615, USN23P0627, USN23P0611, USN23P0683, USN23P0682, USN23P0625, USN23P0173, USN23P0164, US823P0231, USN23P0613, USN23P0172, USN23P0721, USN23P0410, USN23P0612, USN23P0614, USN23P0171, US623P0141, US823P0233, US423P0844, US523P1060, US523P1061, US523P1750, US523P2536, US523P2537, US523P2672, US523P2673, US423P0842, US623P0140, US423P0759, US623P0142, US623P0230, US623P0485, US623P0486, US623P0740, US623P0790, US623P0791, US623P0792, US623P0866, US623P0867, US423P0843, US623P0966, US423P0672, US423P0673, US423P0674, US423P0712, US423P0757, US823P0132, US823P0232, US823P0318, US823P0319, US823P0320, US823P0321, US823P0322, US823P0507, US823P0508, US823P1857, US923P1161, US823P0129, US723P1919, US623P1072, US623P1403, US623P1483, US623P1606, US623P1607, US623P1608, US623P1609, US823P0131, US823P0029, US823P0128, US823P0127, US823P0033, US823P0032, US823P0030, US823P0028, US723P2256, US723P2154, US723P2153, US723P2152, US823P0130, US823P0031, USO23P2173, USO23P2065, US723P1242, US723P1243, US723P1342, US723P1343, US723P1241, US723P1240, USN23P0333, USN23P0332, US623P1450, US723P1766, USO23P0157, USO23P0156, USO23P0059, USO23P0058, US823P1743, US823P1744, US823P1745, US723P1582, US723P1872, US723P1583, USO23P2274, USO23P2064, USO23P2171, US623P1739, US723P1239, US723P1111, USN23P0330, USN23P0331, US923P0205, USN23P0051, US823P1767, US923P0207, US823P1770, US823P1769, US823P1251, US823P1229, US723P0393, US923P0421, USO23P2069; 5500 P/795143/00884838116573/USN23P0048, USN23P0050, USO23P2276, USO23P2275, US523P2372, US523P2538, US523P2406, US523P2405, US523P2374, US523P2373, US523P1837, US523P1838, US623P0741, US523P1839, US823P0744, US823P0745, US723P2257, US823P1030, US823P0877, US823P0548, US823P0547, US823P0546, US823P0511,…
FDA’s list runs to 4,709 characters. The first part is shown; the rest is on FDA’s record.
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 CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates.
The states and territories these words name
26 states and territories.
Every one of them
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Maine
- Michigan
- North Carolina
- New Hampshire
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- 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.
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 Mar 23, 2024.
- FDA classified it on May 3, 2024.
- FDA’s Enforcement Report published it on May 15, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Ultrasound, Inc., of Bothell, WA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 4,709 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.
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.