EPIQ Ultrasound Systems — Class II medical device recall Z-2306-2021
Completed recall by Philips Ultrasound Inc, reported 2021-08-25, distributed nationwide. Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to
| Recall number | Z-2306-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2021-07-22 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| 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, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 8,935 |
Product
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Reason for recall
Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.
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-2306-2021. 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.