3D9-3v Transducer — Class II medical device recall Z-2517-2023
Completed recall by Philips Ultrasound, Inc., reported 2023-09-13, distributed nationwide. Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart
| Recall number | Z-2517-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2023-06-30 |
| Classified | 2023-09-06 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, ES, FR, GR, HU, IT, MX, NL, NZ, SA, TH |
| Quantity | 449 |
| UPC / GTIN / UDI-DI | 00884838061545 |
| Serial numbers | B0T4K4, B0WH4P, B18NV8, B1MKLW, B1YQC1, B23M55, B25331, B2867Q, B2JDYH, B2JFNX, B2PWBT, B2RL1T, B2RVM9, B2ZHB2, B2ZHFB, B2ZHX2, B2ZR05, B2ZVMB, B32MK3, B32MKY, B35BYY, B35JLT, B35JQ4, B3FH7X, B3FT4V and 424 more |
Product
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Reason for recall
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
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-2517-2023. 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.