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 | Ongoing |
| Reason | Transducers (component of ultrasound system) may exceed recommended thermal index limits |
| Product | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , |
| Quantity | 31 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand. |
| Initiated | 2022-03-07 |
| Classified | 2022-04-27 |
| Recall number | Z-1010-2022 |
| 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-1010-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89856/
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