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 reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 5.1 |
| 2019-02 | 0 | 3.3 |
| 2019-03 | 0 | 3.25 |
| 2019-04 | 0 | 5.91 |
| 2019-05 | 0 | 3.25 |
| 2019-06 | 0 | 2.8 |
| 2019-07 | 0 | 2.58 |
| 2019-08 | 0 | 2.43 |
| 2019-09 | 0 | 2.14 |
| 2019-10 | 0 | 2.25 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 5.33 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.75 |
| 2020-03 | 0 | 2.2 |
| 2020-04 | 0 | 3.67 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.44 |
| 2020-07 | 0 | 2.25 |
| 2020-08 | 0 | 1.74 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 2.05 |
| 2020-11 | 0 | 2.24 |
| 2020-12 | 0 | 2.4 |
| 2021-01 | 0 | 1.47 |
| 2021-02 | 0 | 1.81 |
| 2021-03 | 0 | 2.43 |
| 2021-04 | 0 | 2.74 |
| 2021-05 | 0 | 3.77 |
| 2021-06 | 0 | 4.55 |
| 2021-07 | 0 | 3.07 |
| 2021-08 | 0 | 2.53 |
| 2021-09 | 0 | 2.3 |
| 2021-10 | 0 | 1.67 |
| 2021-11 | 0 | 2.62 |
| 2021-12 | 0 | 2.75 |
| 2022-01 | 0 | 1.89 |
| 2022-02 | 0 | 2.47 |
| 2022-03 | 0 | 2.43 |
| 2022-04 | 0 | 2.42 |
| 2022-05 | 0 | 1.89 |
| 2022-06 | 0 | 1.88 |
| 2022-07 | 0 | 3.53 |
| 2022-08 | 0 | 1.86 |
| 2022-09 | 0 | 2.84 |
| 2022-10 | 0 | 2.09 |
| 2022-11 | 0 | 2.07 |
| 2022-12 | 0 | 1.65 |
| 2023-01 | 0 | 2.31 |
| 2023-02 | 0 | 1.9 |
| 2023-03 | 0 | 2.63 |
| 2023-04 | 0 | 2.17 |
| 2023-05 | 0 | 2.57 |
| 2023-06 | 4 | 6.84 |
| 2023-07 | 0 | 2.1 |
| 2023-08 | 0 | 3.42 |
| 2023-09 | 0 | 2.95 |
| 2023-10 | 0 | 5.89 |
| 2023-11 | 0 | 2.58 |
| 2023-12 | 0 | 2.9 |
| 2024-01 | 0 | 1.9 |
| 2024-02 | 0 | 1.88 |
| 2024-03 | 0 | 1.89 |
| 2024-04 | 0 | 1.65 |
| 2024-05 | 0 | 2.06 |
| 2024-06 | 0 | 3.08 |
| 2024-07 | 0 | 1.88 |
| 2024-08 | 0 | 1.3 |
| 2024-09 | 0 | 1.17 |
| 2024-10 | 0 | 1.95 |
| 2024-11 | 0 | 1.45 |
| 2024-12 | 0 | 1.69 |
| 2025-01 | 0 | 1.59 |
| 2025-02 | 0 | 1.61 |
| 2025-03 | 0 | 1.39 |
| 2025-04 | 0 | 1.86 |
| 2025-05 | 0 | 2.5 |
| 2025-06 | 0 | 1.54 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.1 |
| 2025-11 | 0 | 1.29 |
| 2025-12 | 0 | 2.41 |
| 2026-01 | 0 | 2.22 |
| 2026-02 | 0 | 1.68 |
| 2026-03 | 0 | 1.45 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2.19 |
| 2026-06 | 0 | 1.55 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-08-10 | Z-2662-2023 | Class II | Open, Classified | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environmentDistribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW. | 6318 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-06-30 | 3007222345-2023-00070 | Malfunction | Available | catalog number |
Showing the most recent 1 of 4 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-02-23 | VAI | Voluntary action indicated | Veran Medical Technologies Inc | 4 |
| 2021-07-29 | VAI | Voluntary action indicated | Veran Medical Technologies Inc | 0 |
| 2019-01-31 | VAI | Voluntary action indicated | Veran Medical Technologies Inc | 0 |
| 2018-02-23 | VAI | Voluntary action indicated | Veran Medical Technologies Inc | 0 |
| 2015-02-04 | NAI | No action indicated | Veran Medical Technologies Inc | 0 |
| 2010-08-25 | NAI | No action indicated | Veran Medical Technologies Inc | 0 |
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