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Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Recalled February 12, 2020 · FDA recall Z-0981-2020 · Pacific Medical Group
Hazard
Fetal transducers distributed in advance of receiving 510(k) and international clearances. · FDA Class II
Units
295
Sold at
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
Description
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Product
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Manufacturer(s)
Pacific Medical Group Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →