FDA-Device2020-02-12Class II
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Pacific Medical Group Inc.
Hazard
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.
Sold states
U.S.: 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. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE
Affected count
628
Manufactured in
212 Avenida Fabricante, N/A, San Clemente, CA, United States
Products
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0980-2020Don't want to check this manually?
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