Food, drugs, devices › Siemens Medical Solutions USA, Inc.
Device recall: ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number
Siemens Medical Solutions USA, Inc. (Mountain View, CA) initiated this device recall on 29 May 2015; FDA lists 1 product record under event 71469, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 9 Mar 2017. Initiation: voluntary: firm initiated. Siemens Medical Solutions USA, Inc. has 400 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions USA, Inc., Mountain View, CA.
Reason for recall
"When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study."
Distribution
"Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1959-2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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,… | 573 devices | Class II | Terminated | 8 Jul 2015 |
Context
Other enforcement events for Siemens Medical Solutions USA, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jun 2026 | ARTIS icono ceiling. Model Number: 11328100. | Device | Class II | 1 |
| 20 May 2026 | ARTIS icono biplane. Model Number: 11327600. | Device | Class II | 3 |
| 12 Mar 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | Device | Class II | 1 |
| 10 Mar 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | Device | Class II | 1 |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Device | Class II | 2 |
| 29 Dec 2025 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Vers | Device | Class II | 2 |
| 19 Dec 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | Device | Class II | 4 |
| 5 Dec 2025 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | Device | Class II | 1 |
| 24 Oct 2025 | MAMMOMAT Revelation; | Device | Class II | 3 |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Device | Class I | 1 |
All 400 events for Siemens Medical Solutions USA, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.