Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 675 |
| Distribution | Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway,… |
| Initiated | 2014-03-07 |
| Classified | 2014-04-03 |
| Terminated | 2015-11-12 |
| Recall number | Z-1331-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-1331-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67741/
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