Philips EPIQ Diagnostic Ultrasound System — Class II medical device recall Z-0947-2021
Terminated recall by Philips Ultrasound Inc, reported 2021-02-10, distributed nationwide. Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied
| Recall number | Z-0947-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2020-12-24 |
| Classified | 2021-02-03 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 12,080 systems |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838088658 |
| Serial numbers | US119B0804, US119B1008, US119B1009, US119B1010, US119B1011, US119B1090, US119B1399, US119B1400, US119B1417, US119B1499, US119B1500, US119B1501, US119B1502, US119B1503, US119B1512, US119B1553, US119B1557, US119B1712, US119B1728, US119B1761, US119B1776, US119B1912, US119B1913, US119B1914, US119B1915 and 475 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0947-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.