Device product
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Z-0982-2020
Product summary
- Event
- Event 83869
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0982-2020
Official wording
Reason: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Code information: All serial numbers sold between 01/21/2015 - 04/30/2019
Distribution pattern: 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
Derived failure modes
-
Unknown
Fetal transducers distributed in advance of receiving 510(k) and international clearances.