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 | In certain situations, loss of post exercise images can occur in Stress Echo. |
| Product | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. |
| Quantity | 476 |
| Distribution | Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerlan… |
| Initiated | 2012-07-11 |
| Classified | 2015-05-05 |
| Terminated | 2015-05-06 |
| Recall number | Z-1584-2015 |
| 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-1584-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71122/
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