Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841
Medical device recall Z-0883-2026. Published in FDA’s Enforcement Report on Dec 10, 2025.
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 10, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 4,819 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?
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
4,819 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073…
Every code shown here, 2,000 characters
UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L0585 US821L0582 US821L0580 US821L0347 US821L0587 US821L0581 US821L0584 US821L0420 US821L0473 US821L0101 US821L0099 US821L0100 US821L0098 US621L2293 US621L2144 US721L0342 US621L2051 US621L1995 US621L2053 US621L2050 US721L0807 US621L2054 US621L2049 US721L0530 US721L0406 US621L2057 US721L0529 US621L1997 US721L0404 US721L0528 US621L2056 US721L0395 US621L2058 US721L0803 US721L0397 US721L0804 US621L2055 US621L2052 US621L1996 US721L0808 US721L0403 US721L0396 US721L0805 US721L0398 US721L0405 US721L0159…
FDA’s list runs to 53,095 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 AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.
The states and territories these words name
49 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 Oct 31, 2025.
- FDA classified it on Dec 4, 2025.
- FDA’s Enforcement Report published it on Dec 10, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Ultrasound, LLC, 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 53,095 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.