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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.67 |
| 2019-04 | 0 | 2.33 |
| 2019-05 | 0 | 1.25 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1.2 |
| 2019-09 | 0 | 4 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1.33 |
| 2020-01 | 0 | 3.6 |
| 2020-02 | 0 | 1.33 |
| 2020-03 | 0 | 1.83 |
| 2020-04 | 0 | 2.67 |
| 2020-05 | 0 | 4.2 |
| 2020-06 | 0 | 2.6 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 3.4 |
| 2020-10 | 0 | 4.75 |
| 2020-11 | 0 | 2.4 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 1.33 |
| 2021-02 | 0 | 1.67 |
| 2021-03 | 0 | 1.8 |
| 2021-04 | 0 | 1.8 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 3.4 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 1.17 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 0 | 4.25 |
| 2022-01 | 0 | 1.6 |
| 2022-02 | 0 | 1.4 |
| 2022-03 | 0 | 3.4 |
| 2022-04 | 0 | 1.33 |
| 2022-06 | 0 | 2.77 |
| 2022-07 | 0 | 3 |
| 2022-08 | 0 | 2.17 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 0 | 1.33 |
| 2022-11 | 0 | 2.82 |
| 2022-12 | 0 | 1.17 |
| 2023-01 | 0 | 4.57 |
| 2023-02 | 0 | 2.14 |
| 2023-03 | 0 | 3.57 |
| 2023-04 | 0 | 10.1 |
| 2023-05 | 0 | 6.29 |
| 2023-06 | 0 | 4.4 |
| 2023-07 | 1 | 3.22 |
| 2023-08 | 0 | 1.75 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.33 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 1.8 |
| 2024-01 | 0 | 1.17 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.75 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1.25 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 0 | 1.33 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.67 |
| 2025-06 | 0 | 5.67 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.25 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-02-14 | Z-1259-2023 | Class II | Open, Classified | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment TemplateDistribution: US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution. | 56 systems in the U.S. | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-07-26 | 8043933-2023-00055 | Injury | Available | exact di |
Regulatory clearances
- 510(k)K231052Substantially equivalent (SESE) · 2023-05-11clearance family
- 510(k)K220338Substantially equivalent (SESE) · 2022-04-29clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
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