medical Class II Updated 2020-02-12

Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Toco Transducer w/wi

Recalled Product

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

Hazard / Issue

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 pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

Issued by

FDA

Affected States: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH

Lot/Code Info: All serial numbers distributed between 02/06/16 - 04/30/19.

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