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.
4 linked reportsInjury 3Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.7 |
| 2019-02 | 0 | 1.5 |
| 2019-03 | 1 | 1.5 |
| 2019-04 | 0 | 3.14 |
| 2019-05 | 0 | 1.2 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 1 | 1.78 |
| 2019-08 | 0 | 2.29 |
| 2019-09 | 0 | 1.6 |
| 2019-10 | 0 | 2.75 |
| 2019-11 | 0 | 3.4 |
| 2019-12 | 0 | 2.17 |
| 2020-01 | 1 | 1 |
| 2020-02 | 0 | 2.78 |
| 2020-03 | 0 | 2.5 |
| 2020-04 | 0 | 2 |
| 2020-05 | 1 | 1 |
| 2020-06 | 0 | 2.38 |
| 2020-07 | 0 | 3.2 |
| 2020-08 | 0 | 2.5 |
| 2020-09 | 0 | 3.57 |
| 2020-10 | 0 | 2 |
| 2020-11 | 0 | 2.57 |
| 2020-12 | 0 | 3.2 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 3.78 |
| 2021-03 | 0 | 2.5 |
| 2021-04 | 0 | 3.23 |
| 2021-05 | 0 | 2.91 |
| 2021-06 | 0 | 2.5 |
| 2021-07 | 0 | 3.4 |
| 2021-08 | 0 | 1.91 |
| 2021-09 | 0 | 2.62 |
| 2021-10 | 0 | 3.73 |
| 2021-11 | 0 | 2.82 |
| 2021-12 | 0 | 2.36 |
| 2022-01 | 0 | 2.2 |
| 2022-02 | 0 | 4 |
| 2022-03 | 0 | 3.36 |
| 2022-04 | 0 | 2.47 |
| 2022-05 | 0 | 2.7 |
| 2022-06 | 0 | 2.36 |
| 2022-07 | 0 | 2.38 |
| 2022-08 | 0 | 3.08 |
| 2022-09 | 0 | 4.43 |
| 2022-10 | 0 | 9.78 |
| 2022-11 | 0 | 2.79 |
| 2022-12 | 0 | 2.13 |
| 2023-01 | 0 | 2.94 |
| 2023-02 | 0 | 2.35 |
| 2023-03 | 0 | 4.57 |
| 2023-04 | 0 | 3.16 |
| 2023-05 | 0 | 3.15 |
| 2023-06 | 0 | 3 |
| 2023-07 | 0 | 3.24 |
| 2023-08 | 0 | 3.5 |
| 2023-09 | 0 | 2.71 |
| 2023-10 | 0 | 4.25 |
| 2023-11 | 0 | 4.35 |
| 2023-12 | 0 | 4.33 |
| 2024-01 | 0 | 8.47 |
| 2024-02 | 0 | 4.54 |
| 2024-03 | 0 | 5.08 |
| 2024-04 | 0 | 5.24 |
| 2024-05 | 0 | 4.59 |
| 2024-06 | 0 | 4.71 |
| 2024-07 | 0 | 3.95 |
| 2024-08 | 0 | 2.72 |
| 2024-09 | 0 | 3.68 |
| 2024-10 | 0 | 2.86 |
| 2024-11 | 0 | 4.1 |
| 2024-12 | 0 | 4.11 |
| 2025-01 | 0 | 4.18 |
| 2025-02 | 0 | 3.71 |
| 2025-03 | 0 | 4.25 |
| 2025-04 | 0 | 2.97 |
| 2025-05 | 0 | 4.84 |
| 2025-06 | 0 | 4.23 |
| 2025-07 | 0 | 4.62 |
| 2025-08 | 0 | 3.85 |
| 2025-09 | 0 | 5.33 |
| 2025-10 | 0 | 5.63 |
| 2025-11 | 0 | 3.9 |
| 2025-12 | 0 | 6.91 |
| 2026-01 | 0 | 4.47 |
| 2026-02 | 0 | 5.24 |
| 2026-03 | 0 | 5.22 |
| 2026-04 | 0 | 5.67 |
| 2026-05 | 0 | 3.84 |
| 2026-06 | 0 | 5.86 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2020-05-28 | 2939520-2020-00014 | Injury | Available | exact di |
| 2020-01-17 | 2939520-2019-00058 | Injury | Available | exact di |
| 2019-07-10 | 2939520-2019-00040 | Injury | Available | exact di |
| 2019-03-15 | 2939520-2019-00024 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
K050995
Cited as predicate by: K172258
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 |
|---|---|---|---|---|
| 2025-01-08 | NAI | No action indicated | Philips Image Guided Therapy Corporation | 0 |
| 2021-08-27 | NAI | No action indicated | Philips Image Guided Therapy Corporation | 0 |
| 2015-05-28 | VAI | Voluntary action indicated | Philips Image Guided Therapy Corporation | 0 |
| 2012-10-30 | VAI | Voluntary action indicated | Philips Image Guided Therapy Corporation | 1 |
| 2011-12-22 | NAI | No action indicated | Philips Image Guided Therapy Corporation | 0 |
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