Devices › System, imaging, pulsed doppler, ultrasonic
Device brand name · Ultrasound device
ACUSON SC2000 Ultrasound System: medical device reports filed with FDA
221 reports name it, 2015–2026. Manufacturer given most often on reports: Siemens Medical Solutions USA. Product code IYN.
- 221
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 11
- reports, 12 months to August 2026
- 17 in the 12 months before
- 97.7%
- classified as malfunction
- 87.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 221 reports that name the brand "ACUSON SC2000 Ultrasound System" (ultrasound device), received between February 2015 and August 2026; the manufacturer given most often on reports is Siemens Medical Solutions USA. Spellings of one product vary from report to report.
11 reports arrived in the 12 months to August 2026, down 35% from 17 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (97.7%) and injury (2.3%); across all system, imaging, pulsed doppler, ultrasonic reports (product code IYN) death is recorded in 1.3% and malfunction in 87.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operational issue (30.3%), loss of data (28.1%) and data problem (19.9%). The patient problems coded most often are no patient involvement, contact dermatitis and discomfort. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,691 reports carrying product code IYN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device operational issue | 67 | 30.3% | 3.2% |
| Loss of data | 62 | 28.1% | 3.1% |
| Data problem | 44 | 19.9% | 2.3% |
| Application program freezes or fails to launch | 16 | 7.2% | 5.5% |
| Device displays incorrect message | 14 | 6.3% | 1.5% |
| Computer software problema software problem | 11 | 5% | 1.3% |
| No display/image | 9 | 4.1% | 3% |
| Breakthe device broke | 6 | 2.7% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 2.7% | 2.2% |
| Electrical /electronic property probleman electrical or electronic problem | 5 | 2.3% | 3.4% |
| Unexpected shutdown | 5 | 2.3% | 1.7% |
| Application program problem | 4 | 1.8% | 0.3% |
| Temperature problem | 4 | 1.8% | 0.4% |
| Incorrect, inadequate or imprecise result or readings | 3 | 1.4% | 0.4% |
| Mechanics altered | 3 | 1.4% | 0.1% |
| Overheating of device | 3 | 1.4% | 0.4% |
| Circuit failure | 2 | 0.9% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 2 | 0.9% | 0.2% |
| Complete loss of power | 2 | 0.9% | 0.1% |
| Computer operating system problem | 2 | 0.9% | 0.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 5 | 2.3% |
| Contact dermatitis | 1 | 0.5% |
| Discomfortdiscomfort | 1 | 0.5% |
| Erythemaskin redness | 1 | 0.5% |
| Not applicable | 1 | 0.5% |
| Sedationdrowsiness from a medicine | 1 | 0.5% |
| Shockshock, a collapse of the circulation | 1 | 0.5% |
| Superficial (first degree) burn | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ACUSON SC2000 Ultrasound System | Product code IYN | All MAUDE reports |
|---|---|---|---|
| Reports | 221 | 2,691 | 26,136,888 |
| Share of that pool | — | 8.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 13 | 9 |
| Classified as injury | 2.3% | 9.6% | 36.2% |
| Classified as malfunction | 97.7% | 87.8% | 62.3% |
| Filed by the manufacturer | 99.5% | 91.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code IYN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Epiq Cvx | 402 | 122 | 0.2% |
| Epiq 7 | 273 | 71 | 1.1% |
| Acuson | 691 | 0 | 0.4% |
| Acuson Z6ms Ultrasound Transducer | 292 | 3 | 0% |
| HYDROS Robotic System | 164 | 125 | 3% |
| Toshiba | 158 | 0 | 1.9% |
| Philips | 190 | 0 | 6.3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about ACUSON SC2000 Ultrasound System reports
How many FDA reports name ACUSON SC2000 Ultrasound System?
221 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
malfunction (97.7%) and injury (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operational issue (30.3%), loss of data (28.1%), data problem (19.9%), application program freezes or fails to launch (7.2%) and device displays incorrect message (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ACUSON SC2000 Ultrasound System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.