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 |
|---|---|---|---|---|
| 2025-12-04 | NAI | No action indicated | SenDx Medical, Inc. | 0 |
| 2024-09-19 | NAI | No action indicated | Radiometer Medical ApS | 0 |
| 2024-09-19 | NAI | No action indicated | Radiometer Medical ApS | 0 |
| 2017-05-17 | NAI | No action indicated | Radiometer Sp z.o.o. | 0 |
| 2017-05-11 | NAI | No action indicated | Radiometer Medical ApS | 0 |
| 2017-05-11 | NAI | No action indicated | Radiometer Medical ApS | 0 |
| 2016-10-20 | VAI | Voluntary action indicated | Radiometer Basel AG | 2 |
| 2015-03-02 | VAI | Voluntary action indicated | Radiometer America Inc | 4 |
| 2011-08-18 | VAI | Voluntary action indicated | Radiometer America Inc | 3 |
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