Devices › System, imaging, pulsed echo, ultrasonic
Device brand name · Diagnostic ultrasound device
Acuson: medical device reports filed with FDA
691 reports name it, 2001–2016. Manufacturer given most often on reports: Siemens Medical Solutions USA. Product code IYO.
- 691
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.9%
- classified as malfunction
- 95.3% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
691 medical device reports received by FDA name the brand "Acuson" (diagnostic ultrasound device); the manufacturer given most often on reports is Siemens Medical Solutions USA; received from February 2001 to October 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (92.9%), other (3.9%) and injury (2.6%); across all system, imaging, pulsed echo, ultrasonic reports (product code IYO) death is recorded in 0.3% and malfunction in 95.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are computer software problem (9.7%), transducer overheating (8.2%) and electrical /electronic property problem (7.5%). The patient problems coded most often are electric shock, discomfort and pericardial effusion. 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
No report naming Acuson was received in the five years to August 2026; the latest was received in October 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,553 reports carrying product code IYO. 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 |
|---|---|---|---|
| Computer software problema software problem | 67 | 9.7% | 1.6% |
| Transducer overheating | 57 | 8.2% | 0.9% |
| Electrical /electronic property probleman electrical or electronic problem | 52 | 7.5% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 44 | 6.4% | 1.2% |
| Inappropriate/inadequate shock/stimulation | 39 | 5.6% | 0.7% |
| Defective component | 37 | 5.4% | 8% |
| Split | 26 | 3.8% | 0% |
| Data problem | 25 | 3.6% | 1.7% |
| Overheating of device | 24 | 3.5% | 0.6% |
| Transducer failure | 19 | 2.7% | 0.3% |
| Mechanical problema mechanical problem | 18 | 2.6% | 0.1% |
| Date/time-related software problem | 16 | 2.3% | 0.2% |
| Performance | 16 | 2.3% | 0.3% |
| Device displays incorrect message | 15 | 2.2% | 0.6% |
| Breakthe device broke | 13 | 1.9% | 5% |
| Mechanics altered | 13 | 1.9% | 0.1% |
| Unstable | 13 | 1.9% | 0% |
| Loss of data | 12 | 1.7% | 0.7% |
| Computer operating system problem | 11 | 1.6% | 0.3% |
| Device emits odor | 10 | 1.4% | 0.2% |
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 |
|---|---|---|
| Electric shockan electric shock | 51 | 7.4% |
| Discomfortdiscomfort | 13 | 1.9% |
| Pericardial effusionfluid around the heart | 8 | 1.2% |
| Cardiac tamponade | 7 | 1% |
| Low blood pressure/ hypotension | 7 | 1% |
| Perforation | 6 | 0.9% |
| Deaththe patient died; cause not stated by this term | 5 | 0.7% |
| Burn(s)a burn | 4 | 0.6% |
| Cardiac perforation | 4 | 0.6% |
| Therapy/non-surgical treatment, additional | 4 | 0.6% |
| Abrasion | 3 | 0.4% |
| Injurya physical injury | 3 | 0.4% |
| Misdiagnosis | 3 | 0.4% |
| Numbnessnumbness | 3 | 0.4% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Acuson | Product code IYO | All MAUDE reports |
|---|---|---|---|
| Reports | 691 | 6,553 | 26,136,888 |
| Share of that pool | — | 10.5% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 2.6% | 3.7% | 36.2% |
| Classified as malfunction | 92.9% | 95.3% | 62.3% |
| Filed by the manufacturer | 99.6% | 97.8% | 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 IYO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Galaxy Intravascular Ultrasound System | 969 | 0 | 0% |
| Site-Rite 8 Ultrasound | 735 | 0 | 0% |
| Site Rite 8 Ultrasound System 20mm Cue Linear Probe | 490 | 0 | 0% |
| Site Rite 8 Ultrasound System Console With Connector | 400 | 0 | 0% |
| Site~Rite 8 Ultrasound System | 312 | 112 | 0% |
| Site-Rite 8 Ultrasound Systsem Console Remanufactured | 224 | 0 | 0% |
| iLab Ultrasound Imaging System | 1,075 | 85 | 0.2% |
| ACUSON SC2000 Ultrasound System | 221 | 11 | 0% |
| ViewFlex Xtra ICE Catheter | 418 | 66 | 1.2% |
| Bard Tl Cvc Catheter | 213 | 0 | 0% |
| Autoclavable Camera Head | 320 | 55 | 0% |
| Toshiba | 158 | 0 | 1.9% |
| Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray | 309 | 0 | 0% |
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 reports
How many FDA reports name Acuson?
691 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (92.9%), other (3.9%) and injury (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
computer software problem (9.7%), transducer overheating (8.2%), electrical /electronic property problem (7.5%), device operates differently than expected (6.4%) and inappropriate/inadequate shock/stimulation (5.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Acuson 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.