Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Reported: February 12, 2020 Initiated: September 19, 2019 #Z-0981-2020
Product Description
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Reason for Recall
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Details
- Recalling Firm
- Pacific Medical Group Inc.
- Units Affected
- 295
- 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
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205. Recalled by Pacific Medical Group Inc.. Units affected: 295.
Why was this product recalled? ▼
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0981-2020.
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