Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

FDA Device Recall #Z-0983-2020 — Class II — September 19, 2019

Recall Summary

Recall Number Z-0983-2020
Classification Class II — Moderate risk
Date Initiated September 19, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pacific Medical Group Inc.
Location San Clemente, CA
Product Type Devices
Quantity 678

Product Description

Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

Reason for Recall

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

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

Lot / Code Information

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

Other Recalls from Pacific Medical Group Inc.

Recall # Classification Product Date
Z-1375-2021 Class I Aftermarket Alaris Infusion Pump Module Model 8... Mar 24, 2021
Z-0985-2020 Class II Pacific Medical Philips M1356A Ultrasound Trans... Sep 19, 2019
Z-0980-2020 Class II Pacific Medical GE Corometrics Nautilus Toco Tr... Sep 19, 2019
Z-0981-2020 Class II Pacific Medical GE Corometrics Nautilus Ultraso... Sep 19, 2019
Z-0984-2020 Class II Pacific Medical Philips M1355A Toco Transducer ... Sep 19, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.