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.
8 linked reportsMalfunction 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.9 |
| 2019-02 | 0 | 4.93 |
| 2019-03 | 0 | 5.26 |
| 2019-04 | 0 | 3.29 |
| 2019-05 | 0 | 4.86 |
| 2019-06 | 0 | 5.9 |
| 2019-07 | 0 | 4.79 |
| 2019-08 | 0 | 6.75 |
| 2019-09 | 0 | 3.72 |
| 2019-10 | 0 | 3.52 |
| 2019-11 | 0 | 3.98 |
| 2019-12 | 0 | 4.62 |
| 2020-01 | 0 | 2.67 |
| 2020-02 | 0 | 4.83 |
| 2020-03 | 0 | 5.19 |
| 2020-04 | 0 | 4.9 |
| 2020-05 | 0 | 2.74 |
| 2020-06 | 0 | 3.07 |
| 2020-07 | 0 | 4.23 |
| 2020-08 | 0 | 2.92 |
| 2020-09 | 0 | 2.23 |
| 2020-10 | 0 | 3.65 |
| 2020-11 | 0 | 3.84 |
| 2020-12 | 0 | 5.61 |
| 2021-01 | 0 | 6.25 |
| 2021-02 | 0 | 4.5 |
| 2021-03 | 0 | 6.71 |
| 2021-04 | 0 | 4.04 |
| 2021-05 | 0 | 5.64 |
| 2021-06 | 0 | 6.05 |
| 2021-07 | 0 | 7.84 |
| 2021-08 | 0 | 6.58 |
| 2021-09 | 0 | 8.2 |
| 2021-10 | 0 | 5.48 |
| 2021-11 | 0 | 6.42 |
| 2021-12 | 0 | 8.69 |
| 2022-01 | 0 | 5.92 |
| 2022-02 | 0 | 7.87 |
| 2022-03 | 0 | 6.74 |
| 2022-04 | 0 | 7.3 |
| 2022-05 | 0 | 8.86 |
| 2022-06 | 0 | 6.71 |
| 2022-07 | 0 | 6.64 |
| 2022-08 | 0 | 5.04 |
| 2022-09 | 0 | 4.65 |
| 2022-10 | 0 | 5.25 |
| 2022-11 | 0 | 3.98 |
| 2022-12 | 0 | 4.54 |
| 2023-01 | 0 | 4.53 |
| 2023-02 | 0 | 3.97 |
| 2023-03 | 0 | 5.49 |
| 2023-04 | 0 | 3.6 |
| 2023-05 | 0 | 5.6 |
| 2023-06 | 0 | 3.86 |
| 2023-07 | 0 | 3.96 |
| 2023-08 | 0 | 5.33 |
| 2023-09 | 0 | 5.18 |
| 2023-10 | 0 | 6.24 |
| 2023-11 | 0 | 5.17 |
| 2023-12 | 0 | 5.22 |
| 2024-01 | 0 | 6.67 |
| 2024-02 | 0 | 4.25 |
| 2024-03 | 0 | 5.78 |
| 2024-04 | 0 | 5.68 |
| 2024-05 | 0 | 4.2 |
| 2024-06 | 0 | 5.61 |
| 2024-07 | 0 | 4.72 |
| 2024-08 | 0 | 4.95 |
| 2024-09 | 0 | 5.38 |
| 2024-10 | 0 | 5.73 |
| 2024-11 | 0 | 4.02 |
| 2024-12 | 0 | 9.71 |
| 2025-01 | 2 | 4.23 |
| 2025-02 | 0 | 3.92 |
| 2025-03 | 0 | 5.34 |
| 2025-04 | 0 | 3.13 |
| 2025-05 | 0 | 3.98 |
| 2025-06 | 0 | 4.03 |
| 2025-07 | 0 | 4.12 |
| 2025-08 | 0 | 5.14 |
| 2025-09 | 0 | 6.11 |
| 2025-10 | 0 | 8.72 |
| 2025-11 | 0 | 10.51 |
| 2025-12 | 0 | 16.05 |
| 2026-01 | 0 | 10.05 |
| 2026-02 | 0 | 6.2 |
| 2026-03 | 2 | 7.73 |
| 2026-04 | 4 | 10.54 |
| 2026-05 | 0 | 14.08 |
| 2026-06 | 0 | 13.59 |
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-07 | 3023245-2026-00032 | Malfunction | Available | exact di |
| 2026-04-07 | 3023245-2026-00030 | Malfunction | Available | catalog number |
| 2026-03-12 | 3023245-2026-00027 | Malfunction | Available | exact di |
| 2025-01-23 | 3009498591-2025-00001 | Malfunction | Available | catalog number |
Showing the most recent 4 of 8 linked reports.
Regulatory clearances
- 510(k)K260844Substantially equivalent (SESE) · 2026-06-16clearance family
- 510(k)K251481Substantially equivalent (SESE) · 2025-08-20clearance family
- 510(k)K242523Substantially equivalent (SESE) · 2024-11-19clearance family
- 510(k)K240704Substantially equivalent (SESE) · 2024-07-22clearance family
- 510(k)K232145Substantially equivalent (SESE) · 2023-10-30clearance family
Predicate lineage
- K240704
Cited as predicate by: K242523
- K242523
Cited as predicate by: K251481
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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