Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

Recall date

September 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0982-2020

FDA classification

Class II

Brand / firm

Pacific Medical Group Inc.

Sold / distributed

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

Why it was recalled

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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