Medium RiskFDA Device

Pacific Medical Group Inc.: Fetal transducers distributed in advance of receiving 510(k) and international clearances.; Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressur

Agency Publication Date: February 4, 2020

Affected Products

Product: Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

All serial numbers sold between 02/06/2016 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

All serial numbers distributed between 02/06/16 - 04/30/19.

Product: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

All serial numbers sold between 10/24/2014 - 04/30/2019

Product: Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

All serial numbers sold between 01/21/2015 - 04/30/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83869

Status: Active

Manufacturer: Pacific Medical Group Inc.

Manufactured In: United States

Units Affected: 7 products (772; 628; 295; 4; 678; 261; 225)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

All serial numbers sold between 02/06/2016 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

All serial numbers distributed between 02/06/16 - 04/30/19.

Product: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

All serial numbers sold between 01/21/2015 - 04/30/2019

Product: Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

All serial numbers sold between 10/24/2014 - 04/30/2019

Product: Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

All serial numbers sold between 01/21/2015 - 04/30/2019