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Hi-bebe
Bistos Co., Ltd. · Model BT-200C · UDI-DI 00887529000199
HGM
Prescription
1
510(k) clearances
1,199
Adverse events (195 deaths)
28
Recalls
56
Facilities
Description
BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker.
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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Get your free API keyRead the docsData 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.