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Mothership Wireless Transducers, Loop Style

TENACORE HOLDINGS, INC. · Model F1 · UDI-DI 00852189007383

HGM Prescription

510(k) clearances

1,221

Adverse events (195 deaths)

Recalls

Facilities

Description

Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.

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.