FDAFDA · Food and drugs·Recall number Z-0983-2020
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Published February 12, 2020 · Recall initiated: September 19, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pacific Medical Group Inc.
- Distributor
- 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
- Lot
- All serial numbers sold between 01/21/2015 - 04/30/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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