Lower risk Medical device recall · FDA · Published September 19, 2019

Pacific Medical GE Corometrics Ultrasound Transducer Recall: Fetal Transducers Distributed

Pacific Medical recalls GE Corometrics Nautilus Ultrasound Transducer models 5700LAX (FFCM5260) sold between Jan 2015 and Apr 2019 due to distribution before required 510(k) clearance for fetal use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0983-2020Medical device Pacific Medical ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmPacific Medical Group Inc.212 Avenida Fabricante · San Clemente, CA 92672-7538

✎ GovInfoNow plain-language explainer

Pacific Medical is recalling GE Corometrics Nautilus Ultrasound Transducers with serial numbers from January 2015 to April 2019 because they were distributed before receiving necessary regulatory clearance for fetal use. This could pose a risk if used on pregnant patients without proper approval. Read more at govinfonow.com/recall/66976-pacific-medical-ge-corometrics-ultrasound-transducer-recall-fetal-transducers-distributed.

Source Summary by GovInfoNow · govinfonow.com/recall/66976-pacific-medical-ge-corometrics-ultrasound-transducer-recall-fetal-transducers-distributed · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0983-2020

Cite this page

“Pacific Medical GE Corometrics Ultrasound Transducer Recall: Fetal Transducers Distributed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66976-pacific-medical-ge-corometrics-ultrasound-transducer-recall-fetal-transducers-distributed. Based on FDA recall #Z-0983-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0983-2020%22&limit=1).

Pacific Medical Group Inc. recalled Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 because fetal transducers were distributed before receiving required clearances, the FDA said on Sept. 19, 2019.

How to tell if you have it

Brand: Pacific Medical
Product: GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Serial numbers sold between 01/21/2015 - 04/30/2019

The hazard

The recall involves fetal transducers distributed in advance of receiving 510(k) and international clearances.

Context

GovInfoNow's records show Pacific Medical Group Inc. has two other recalls on record since Sept. 11, 2019. Other recent recalls of similar products include Koven BiDop 3 Pocket Doppler: Fetal Use Not FDA-Cleared (March 4, 2026), Changchun Wancheng Male Fertility Sperm Test Cassette (Nov. 22, 2025), and Paradise Ultrasound Renal Denervation Catheter Recall: Nonconforming Product Hazard (Jan. 29, 2026).

How to tell if you have this one

Check for the model number 5700LAX with serial numbers sold between January 2015 and April 2019. The product is manufactured by Pacific Medical Group Inc. and sold under the GE Corometrics brand.

Brand
Pacific Medical
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-0979-2020	Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205; All serial numbers sold between 02/06/2016 - 04/30/2019	772
Z-0980-2020	Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260; All serial numbers distributed between 02/06/16 - 04/30/19.	628
Z-0981-2020	Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205; All serial numbers sold between 01/21/2015 - 04/30/2019	295
Z-0982-2020	Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660; All serial numbers sold between 01/21/2015 - 04/30/2019	4
Z-0983-2020	Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260; All serial numbers sold between 01/21/2015 - 04/30/2019	678
Z-0984-2020	Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250; All serial numbers sold between 10/24/2014 - 04/30/2019	261
Z-0985-2020	Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250; All serial numbers sold between 01/21/2015 - 04/30/2019	225

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your transducer has a serial number from January 2015 to April 2019.

Where it went and when

Where it was distributed

Distributed in 44 states and D.C., and outside the U.S.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 5 months after the firm started it.

Sep 19, 2019Firm started the recall
Feb 4, 2020FDA classified it Class II
Feb 12, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Pacific Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/66976-pacific-medical-ge-corometrics-ultrasound-transducer-recall-fetal-transducers-distributed">Pacific Medical GE Corometrics Ultrasound Transducer Recall: Fetal Transducers Distributed (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0983-2020 (September 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0983-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.