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Bistos Co., Ltd. · Model BT-300 · UDI-DI 00887529000106

HGM Prescription

510(k) clearances

1,199

Adverse events (195 deaths)

Recalls

Facilities

Description

BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus.

Recalls

Date	Firm	Reason
2026-05-26	Philips North America Llc	Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe
2026-05-26	Philips North America Llc	Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe
2025-10-24	Edan Diagnostics	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
2025-10-24	Edan Diagnostics	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
2025-10-24	Edan Diagnostics	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
2024-05-22	Philips North America Llc	Potential for inaccurate fetal heart rate measurements when monitoring multiples.
2019-09-19	Pacific Medical Group Inc.	Fetal transducers distributed in advance of receiving 510(k) and international clearances.
2019-09-19	Pacific Medical Group Inc.	Fetal transducers distributed in advance of receiving 510(k) and international clearances.
2019-09-19	Pacific Medical Group Inc.	Fetal transducers distributed in advance of receiving 510(k) and international clearances.
2019-09-19	Pacific Medical Group Inc.	Fetal transducers distributed in advance of receiving 510(k) and international clearances.

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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.