Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
19 linked reportsMalfunction 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.23 |
| 2019-02 | 0 | 5.92 |
| 2019-03 | 0 | 5.89 |
| 2019-04 | 0 | 3.74 |
| 2019-05 | 0 | 6.02 |
| 2019-06 | 0 | 6.6 |
| 2019-07 | 0 | 5.6 |
| 2019-08 | 0 | 8.63 |
| 2019-09 | 0 | 4.42 |
| 2019-10 | 0 | 3.91 |
| 2019-11 | 0 | 4.48 |
| 2019-12 | 0 | 5.3 |
| 2020-01 | 0 | 2.85 |
| 2020-02 | 0 | 5.92 |
| 2020-03 | 0 | 5.97 |
| 2020-04 | 0 | 6.09 |
| 2020-05 | 0 | 3.1 |
| 2020-06 | 0 | 3.01 |
| 2020-07 | 0 | 4.2 |
| 2020-08 | 0 | 2.96 |
| 2020-09 | 0 | 2.16 |
| 2020-10 | 0 | 3.61 |
| 2020-11 | 0 | 3.72 |
| 2020-12 | 0 | 5.46 |
| 2021-01 | 0 | 5.99 |
| 2021-02 | 0 | 4.4 |
| 2021-03 | 0 | 6.39 |
| 2021-04 | 0 | 4 |
| 2021-05 | 0 | 5.5 |
| 2021-06 | 0 | 5.74 |
| 2021-07 | 0 | 7.43 |
| 2021-08 | 0 | 6.32 |
| 2021-09 | 0 | 7.65 |
| 2021-10 | 0 | 5.27 |
| 2021-11 | 0 | 6.11 |
| 2021-12 | 0 | 8.24 |
| 2022-01 | 0 | 5.75 |
| 2022-02 | 0 | 7.01 |
| 2022-03 | 0 | 6.43 |
| 2022-04 | 0 | 6.79 |
| 2022-05 | 0 | 8.19 |
| 2022-06 | 0 | 6.4 |
| 2022-07 | 0 | 6.15 |
| 2022-08 | 0 | 4.78 |
| 2022-09 | 0 | 4.52 |
| 2022-10 | 0 | 5.31 |
| 2022-11 | 0 | 3.89 |
| 2022-12 | 0 | 4.27 |
| 2023-01 | 0 | 4.41 |
| 2023-02 | 0 | 4.03 |
| 2023-03 | 0 | 5.07 |
| 2023-04 | 0 | 3.51 |
| 2023-05 | 0 | 4.97 |
| 2023-06 | 0 | 3.82 |
| 2023-07 | 0 | 3.91 |
| 2023-08 | 0 | 5.15 |
| 2023-09 | 0 | 4.64 |
| 2023-10 | 0 | 5.92 |
| 2023-11 | 0 | 4.75 |
| 2023-12 | 0 | 4.63 |
| 2024-01 | 0 | 6.01 |
| 2024-02 | 0 | 4.12 |
| 2024-03 | 0 | 5.26 |
| 2024-04 | 0 | 5.57 |
| 2024-05 | 0 | 3.95 |
| 2024-06 | 0 | 5.1 |
| 2024-07 | 0 | 4.54 |
| 2024-08 | 0 | 4.72 |
| 2024-09 | 0 | 5.16 |
| 2024-10 | 0 | 5.48 |
| 2024-11 | 0 | 3.95 |
| 2024-12 | 0 | 8.83 |
| 2025-01 | 0 | 4.72 |
| 2025-02 | 5 | 4.38 |
| 2025-03 | 1 | 4.92 |
| 2025-04 | 0 | 3.11 |
| 2025-05 | 1 | 3.84 |
| 2025-06 | 0 | 3.95 |
| 2025-07 | 1 | 4.07 |
| 2025-08 | 0 | 5.1 |
| 2025-09 | 0 | 5.8 |
| 2025-10 | 3 | 9.1 |
| 2025-11 | 0 | 10.06 |
| 2025-12 | 0 | 15.43 |
| 2026-01 | 0 | 10.26 |
| 2026-02 | 3 | 6.14 |
| 2026-03 | 1 | 9.15 |
| 2026-04 | 1 | 11.17 |
| 2026-05 | 3 | 15.39 |
| 2026-06 | 0 | 13.56 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2018-03-05 | Z-1200-2018 | Class II | Terminated | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.Distribution: Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam. | 229 systems | clearance family |
| 2018-01-26 | Z-1065-2018 | Class II | Terminated | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.Distribution: Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, U.A.E, Ukraine, United Kingdom, United States, Uzbekistan, and Vietnam. | 564 systems | clearance family |
| 2011-02-04 | Z-1907-2011 | Terminated | When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use. | — | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-19 | 3023245-2026-00035 | Malfunction | Available | model number |
| 2026-05-19 | 3023245-2026-00036 | Malfunction | Available | model number |
| 2026-05-19 | 3023245-2026-00037 | Malfunction | Available | model number |
| 2026-04-07 | 3023245-2026-00031 | Malfunction | Available | exact di |
| 2026-03-13 | 3023245-2026-00028 | Malfunction | Available | model number |
| 2026-02-27 | 3023245-2026-00022 | Malfunction | Available | model number |
| 2026-02-18 | 3023245-2026-00012 | Malfunction | Available | exact di |
| 2026-02-18 | 3023245-2026-00018 | Malfunction | Available | exact di |
| 2025-10-29 | 3023245-2025-00070 | Malfunction | Available | exact di |
| 2025-10-12 | 3023245-2025-00065 | Malfunction | Available | exact di |
| 2025-10-12 | 3023245-2025-00064 | Malfunction | Available | exact di |
| 2025-07-01 | 3023245-2025-00054 | Malfunction | Available | exact di |
| 2025-05-19 | 3023245-2025-00046 | Malfunction | Available | exact di |
| 2025-03-16 | 3023245-2025-00037 | Malfunction | Available | exact di |
| 2025-02-03 | 3023245-2025-00018 | Malfunction | Available | exact di |
Showing 1–15 of 19
Regulatory clearances
- 510(k)K233613Substantially equivalent (SESE) · 2024-06-12clearance family
- 510(k)K211726Substantially equivalent (SESE) · 2021-11-05clearance family
- 510(k)K202683Substantially equivalent (SESE) · 2020-10-15clearance family
- 510(k)K181098Substantially equivalent (SESE) · 2018-05-31clearance family
- 510(k)K170315Substantially equivalent (SESE) · 2017-04-04clearance family
- 510(k)K162221Substantially equivalent (SESE) · 2016-09-06clearance family
- 510(k)K142395Substantially equivalent (SESE) · 2014-09-09clearance family
- 510(k)K141846Substantially equivalent (SESE) · 2014-08-07clearance family
- 510(k)K132654Substantially equivalent (SESE) · 2013-09-26clearance family
- 510(k)K130754Substantially equivalent (SESE) · 2013-03-25clearance family
- 510(k)K113179Substantially equivalent (SESE) · 2011-12-07clearance family
- 510(k)K102017Substantially equivalent (SESE) · 2010-09-20clearance family
Predicate lineage
- K113179
- K130754
Cited as predicate by: K132654
- K132654
Cited as predicate by: K142395, K152469, K160853, K161787, K163396, K180039, K200780, K201130, K202683
- K162221
- K170315
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-01-31 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2024-01-31 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2023-01-06 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 5 |
| 2023-01-06 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 5 |
| 2022-10-26 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc | 3 |
| 2019-09-18 | NAI | No action indicated | Siemens Medical Solutions USA Inc | 0 |
| 2019-06-10 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-10 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-06 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2017-04-27 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2016-04-15 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 2 |
| 2015-09-09 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2015-09-09 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2015-03-27 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 6 |
| 2014-12-12 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2014-12-12 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2014-11-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc | 0 |
| 2014-07-25 | NAI | No action indicated | Siemens Medical Solutions USA Inc | 3 |
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