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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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.

3 linked reportsMalfunction 3
23562019-01: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 1/device2019-09: 1 reports for this device; peer average 1/device2019-10: 1 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 6/device2023-11: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 2/device2024-12: 1 reports for this device2025-02: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 3/device010809101204020406110312020512
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0801
2019-0911
2019-1011
2019-1201
2020-0401
2021-0202
2022-0401
2022-0606
2023-1106
2024-0302
2024-121—
2025-0202
2025-0501.33
2025-1203
This device (reports/month)Average device in KLT (reports/device/month)
Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-10-302432235-2019-00404MalfunctionAvailableexact di
2019-09-302432235-2019-00349MalfunctionAvailableexact di

Showing the most recent 2 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-26NAINo action indicatedSiemens Healthcare Diagnostics Products Ltd.0
2013-01-24NAINo action indicatedSiemens Healthcare Diagnostics Products GmbH0
2010-07-01NAINo action indicatedSiemens Healthcare Diagnostics Products Ltd.0
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