CLASS II ONGOING Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Pacific Medical GE Corometrics Nautilus Ultrasound recalled

Pacific Medical Group is recalling Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205, distributed in 45 states. The recall was initiated on 19 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers sold between 01/21/2015 - 04/30/2019

Quantity recalled295

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0981-2020
FDA event ID: 83869
Recalling firm: Pacific Medical Group, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Sep 2019
FDA classified: 4 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 Sep 2019	Recall initiated by company
4 Feb 2020	Classified by FDA	+138 days
12 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205

Where it was distributed

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

Alaska Alabama Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Is Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 recalled?

Yes. Pacific Medical Group recalled Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 on 19 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-0981-2020.

Why was it recalled?

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

Which lots are affected?

All serial numbers sold between 01/21/2015 - 04/30/2019

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Pacific Medical Group

All 18

Reported	Class	Recall	Company	Reason	Where
28 Apr 2021Device	CLASS I	Aftermarket Alaris Infusion Pump Module recalled	Pacific Medical Group	Lead & Heavy Metals	Nationwide
19 Feb 2020Device	CLASS II	Ultrasound Transducer (M2736A) recalled by Pacific Medical Group	Pacific Medical Group	Temperature Abuse	Nationwide
19 Feb 2020Device	CLASS II	Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX recalled	Pacific Medical Group	Temperature Abuse	Nationwide
19 Feb 2020Device	CLASS II	Toco+ transducer with ECG/IUP capability (wired) recalled	Pacific Medical Group	Temperature Abuse	Nationwide
19 Feb 2020Device	CLASS II	External Toco Transducer (M1355A) recalled by Pacific Medical Group	Pacific Medical Group	Temperature Abuse	Nationwide

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