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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-15 | WL | Warning Letter | Nihon Kohden Digital Health Solutions, LLC. | — |
| 2026-01-13 | NAI | No action indicated | Nihon Kohden America Fulfillment Center | 0 |
| 2024-10-04 | VAI | Voluntary action indicated | Nihon Kohden America LLC | 0 |
| 2024-01-26 | NAI | No action indicated | Nihon Kohden Kawamoto Corp. | 0 |
| 2024-01-24 | VAI | Voluntary action indicated | Nihon Kohden Corporation - Tokorozawa Technical Center | 0 |
| 2023-06-13 | NAI | No action indicated | Nihon Kohden Digital Health Solutions, LLC. | 0 |
| 2021-05-03 | NAI | No action indicated | Nihon Kohden America LLC | 0 |
| 2019-04-30 | VAI | Voluntary action indicated | Nihon Kohden America LLC | 6 |
| 2017-10-26 | NAI | No action indicated | Nihon Kohden America LLC | 0 |
| 2016-05-13 | NAI | No action indicated | Nihon Kohden Digital Health Solutions, LLC. | 0 |
| 2016-03-25 | NAI | No action indicated | Nihon Kohden Tomioka Corporation | 0 |
| 2014-04-24 | VAI | Voluntary action indicated | Nihon Kohden America LLC | 0 |
| 2011-12-13 | NAI | No action indicated | Nihon Kohden Corp. | 0 |
| 2011-12-13 | NAI | No action indicated | Nihon Kohden Corp. | 0 |
| 2011-12-12 | NAI | No action indicated | Nihon Kohden Kawamoto Corp. | 0 |
| 2011-12-09 | NAI | No action indicated | Nihon Kohden Tomioka Corporation | 0 |
| 2011-08-05 | NAI | No action indicated | Nihon Kohden Digital Health Solutions, LLC. | 0 |
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