Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C,…
Medical device recall Z-0947-2021. Published in FDA’s Enforcement Report on Feb 10, 2021.
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 Feb 10, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 12,080 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?
Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
12,080 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256…
Every code shown here, 2,000 characters
Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256 (01)00884838088658(21)US220B1203 (01)00884838088658(21)US919B0305 (01)00884838088658(21)USN19B1106 (01)00884838088658(21)US220B1587 (01)00884838088658(21)US919B1343 (01)00884838088658(21)USO19B0137 (01)00884838088658(21)USO19B2575 (01)00884838088658(21)US120B0933 (01)00884838088658(21)US619B1530 (01)00884838088658(21)US420B2445 (01)00884838088658(21)US420B2446 (01)00884838088658(21)US520B1252 (01)00884838088658(21)US520B1253 (01)00884838088658(21)US520B1254 (01)00884838088658(21)US620B2080 (01)00884838088658(21)US620B2081 (01)00884838088658(21)US620B2082 (01)00884838088658(21)US619B1796 (01)00884838088658(21)US520B0405 (01)00884838088658(21)US520B0407 (01)00884838088658(21)US520B0408 (01)00884838088658(21)US520B0404 (01)00884838088658(21)US520B0412 (01)00884838088658(21)US620B0625 (01)00884838088658(21)US620B0626 (01)00884838088658(21)US620B0627 (01)00884838088658(21)US620B0628 (01)00884838088658(21)US620B0629 (01)00884838088658(21)US620B0630 (01)00884838088658(21)US720B1295 Serial Numbers: US820C0578 US119B1417 US119B1557 US120C0464 US319B0073 US719B1853 US719B1854 USN19B2032 US819B2075 USO19B0691 USO19B1741 US619B0221 US619C0415 US220B0520 US819C0242 US719B2105 US719B2106 US819C0243 US819C1639 US819C1640 US519B0996 US619C0505 US819C0501 US820B1506 US820B1549 USN19C1237 US720C0111 US720C0112 US320C1372 US420C2439 US519B1596 US519B1597 US520B0086 US819C2072 US820B1501 US820B1502 US220C1669 US519C1368 US219B0988 US320C1373 US519C0081 US819C1783 US519B1562 US320C1367 US919C0241 US919C0242 US819C1181 US919C0313 US220B0862 US819B1736 US819B1737 US919C0491 US919C0045 USN19C1112 US220C0472 US519C0803 US519C0802 USN19C0635 US220C1665 US320C0120 US919C0487 US820B1491 US820B1492 US820B1493 US820B1494 US820B1495 US820B1496 US920B0268 US919C1906 US320C0355…
FDA’s list runs to 143,586 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 distribution - US Nationwide, Puerto Rico, and Virgin Islands. O.U.S.: AE - United Arab Emirates AL - Albania AM - Armenia AR - Argentina AT - Austria AU - Australia AZ - Azerbaijan BA - Bosnia BD - Bangladesh BE - Belgium BG - Bulgaria BH - Bahrain BN - Brunei BO - Bolivia BR - Brazil BY - Belarus CA - Canada CH - Switzerland CL - Chile CN - China CO Colombia CR Costa Rica CY - Cyprus CZ Czech Republic DE - Germany DK - Denmark DO Dominican Republic DZ - Algeria EC - Ecuador EE - Estonia EG - Egypt ES - Spain ET - Ethiopia FI - Fiji FR - France GB United Kingdom GF French Guiana GP - Guadeloupe GR - Greece GT - Guatemala HK Hong Kong HN - Honduras HR - Croatia HU - Hungary ID - Indonesia IE - Ireland IL - Israel IN - India IR - Iran IT - Italy JO - Jordan JP - Japan KE - Kenya KH - Cambodia KR South Korea KW - Kuwait KZ - Kazakhstan LB - Lebanon LK Sri Lanka LT - Lithuania LU - Luxembourg LV - Latvia LY - Libyan MA - Morocco MC - Monaco MD Republic of Moldova ME - Montenegro MM - Myanmar MO - Macau MQ - Martinique MT - Malta MU Mauritius MX Mexico MY Malaysia NC New Caledonia NI - Nicaragua NL - Netherlands NO - Norway NZ New Zealand OM - Oman PA - Panama PE - Peru PF French Polynesia PH - Philippines PK - Pakistan PL - Poland PS - Palestinian PT - Portugal QA - Qatar RE - Reunion RO - Romania RS - Serbia RU - Russia SA Saudi Arabia SE - Sweden SG - Singapore SI - Slovenia SK - Slovakia TH - Thailand TM - Turkmenistan TN - Tunisia TR - Turkey TT - Trinidad TW - Taiwan UA - Ukraine UY - Uruguay UZ - Uzbekistan VN - Vietnam ZA South Africa
The states and territories these words name
- Puerto Rico
- US Virgin Islands
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Dec 24, 2020.
- FDA classified it on Feb 3, 2021.
- FDA’s Enforcement Report published it on Feb 10, 2021.
- FDA terminated it on Mar 21, 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.”
- FDA’s list of codes runs to 143,586 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
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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.