HeraBEAT

HERA MED LTD · Model HeraBEAT US · UDI-DI 07290111520129

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510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

HeraBEAT US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate “crosstalk” in the FHR display.

Recalls

Date	Firm	Reason
2017-10-06	CooperSurgical, Inc.	The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.