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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
DateTypeOutcomeFacilityCitations
2026-04-06VAIVoluntary action indicatedVasomedical Inc1
2026-04-06VAIVoluntary action indicatedVasomedical Inc1
2023-01-09VAIVoluntary action indicatedVasomedical Inc1
2023-01-09VAIVoluntary action indicatedVasomedical Inc1
2019-12-16VAIVoluntary action indicatedVasomedical Inc2
2019-12-16VAIVoluntary action indicatedVasomedical Inc2
2016-03-14VAIVoluntary action indicatedVasomedical Inc3
2016-03-14VAIVoluntary action indicatedVasomedical Inc3
2014-07-03VAIVoluntary action indicatedBiox Instruments Co., Ltd.4
2014-06-03VAIVoluntary action indicatedVasomedical Inc4
2014-06-03VAIVoluntary action indicatedVasomedical Inc4
2012-01-20VAIVoluntary action indicatedVasomedical Inc3
2012-01-20VAIVoluntary action indicatedVasomedical Inc3
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