5000 Compact Series Ultrasound Systems — Class II medical device recall Z-1757-2024
Ongoing recall by Philips Ultrasound, Inc., reported 2024-05-15, distributed nationwide. Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 no
| Recall number | Z-1757-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2024-03-23 |
| Classified | 2024-05-03 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BG, BH, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HR, IT, JP, LT, NL, NZ, OM, PL, RO, SE, SI, ZA |
| Quantity | 363 |
| UPC / GTIN / UDI-DI | 00884838116566, 00884838116573, 00884838116580, 00884838116597, 00884838116603, 00884838116610, 00884838116627 |
| Serial numbers | 505500, 5300, 5500, US223P0650, US223P0651, US423P0672, US423P0673, US423P0674, US423P0712, US423P0714, US423P0757, US423P0759, US423P0842, US423P0843, US423P0844, US423P0993, US423P0994, US423P0995, US523P0946, US523P1060, US523P1061, US523P1439, US523P1440, US523P1749, US523P1750 and 334 more |
| Model numbers | 5300, 5500, CV/795141, G/795145, G/795148, P/795143, P/795147, W/795144, W/795146 |
Product
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
Reason for recall
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
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-1757-2024. 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.