Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W…
Medical device recall Z-0283-2024. Published in FDA’s Enforcement Report on Nov 15, 2023.
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 Nov 15, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- 17 states named in where it went
- 83 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?
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
83 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Following model numbers and serial numbers operating with software version 10.0: Model 795200/UDI:(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185…
Every code shown here, 1,382 characters
Following model numbers and serial numbers operating with software version 10.0: Model 795200/UDI:(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185 US617B1186 US617B1187 US318B2182 USN19B1084 USD13B0543 US419B1858 US419B1860 US419B1949; Model 795201/UDI:(01)00884838047693/Serial Number: USN16B0579; Model # 795202/UDI: (01)00884838047693/ Serial Numbers: US416B1186 US813B0429 US813B0430 US813B0432 USD16B1124 USD16B1126 USD16B1129 US419B1141 US419B1142 US419B1143 US419B1289 USO18B1195; Model 795204/ UDI: (01)00884838047686/ Serial Numbers: US220C0963 US818C1422 US818C1432 US818C1433 US818C1434 US719C0684; model # 795206/ UDI: (01)00884838047686/ Serial Numbers: USD16C1116 USD17C0754 USD18C0039 USO15C0951 US320C0864 Model # 795231/ UDI: (01)00884838114135/ Serial numbers: US723B1124 US120B0345 US120B0348 US120B1131 US723B1125 US723B1121 US723B1122 US723B1123; Model # 795234/UDI: (01)00884838107540/ Serial numbers: USO22B0941 US322B0678 US322B0676 US723B1023 US723B1126 US723B1024 US723B1022 US723B1128 US723B1127 US423B1238 US723B1021 US521B1455 US723B1017 US323B2026 US723B1018 US723B1019 US223B1718 US223B1719 US223B1720 USD22B0063 US323B0675 US723B1020 US523B0298 US523B0299 US523B0300 US523B2699 US523B2700 US523B2701 US523B2702 US523B2703 US523B2704 US523B2705 US523B2873 US523B2872
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.
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
The states and territories these words name
17 states and territories.
Every one of them
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Kentucky
- Maryland
- Montana
- Nebraska
- Nevada
- Ohio
- Tennessee
- Texas
- Utah
- Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, 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 9, 2023.
- FDA classified it on Nov 8, 2023.
- FDA’s Enforcement Report published it on Nov 15, 2023.
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.”
- 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
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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.