Siemens Medical Solutions — Class II medical device recall Z-1331-2014
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-04-09. ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% s
| Recall number | Z-1331-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA, United States |
| Recall initiated | 2014-03-07 |
| Classified | 2014-04-03 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2015-11-12 |
| Countries outside the US | AE, AT, AU, BE, BG, BO, CA, CH, CL, CO, DE, DK, EC, ES, FR, GB, GR, HR, ID, IE, IL, IN, IT, JP, KR, KW, MA, MY, NL, NO, PE, PH, PL, PT, RO, RS, SA, SG, TR, TT, TW, ZA |
| Quantity | 675 |
| Serial numbers | 105, 106, 114, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137 and 475 more |
| Model numbers | 10433816, 10852384, 320E, P300PA |
Product
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Reason for recall
ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.
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-1331-2014. 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.