Acuson 9vE4 Transducer — Class II medical device recall Z-1010-2022
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2022-05-04, distributed nationwide. Transducers (component of ultrasound system) may exceed recommended thermal index limits
| Recall number | Z-1010-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Issaquah, WA, United States |
| Recall initiated | 2022-03-07 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CZ, FR, GB, ID, MX, NZ |
| Quantity | 31 units |
| UPC / GTIN / UDI-DI | 04056869243566 |
| Serial numbers | BT00248, BT10481, BT10488, BT10494, BT10497, BT10580, BT10581, BT10582, BT10584, BT10610, BT10611, BT10612, BT10613, BT10614, BT10615, BT10617, BT10619, BT10640, BT10641, BT10643, BT10644, BT10657, BT10659, BT10661, BT10667 and 3 more |
| Model numbers | CE0129 |
Product
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Reason for recall
Transducers (component of ultrasound system) may exceed recommended thermal index limits
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-1010-2022. 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.