FDA recall Z-0983-2020

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2019-09-19

Report date

2020-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2020