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Recall Observatory FDA recall evidence

Device product

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

Z-0982-2020

September 19, 2019

Class II

Product summary

Firm
Pacific Medical Group Inc.
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

    reason.no_named_rule · v1.0.0

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