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Use caution Medical device recall · FDA · Published September 11, 2019

Pacific Medical Ultrasound Transducer M1356A Recall: Risk of Inaccurate Fetal Monitoring

Pacific Medical recalls ultrasound transducers M1356A that may have been serviced with non-OEM parts between Dec 2014 and Apr 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and maternal health, risking undetected distress.

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

🇺🇸 FDA recall #Z-1164-2020Medical devicePacific Medical ›
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Contact the company

Recalling firmPacific Medical Group Inc.212 Avenida Fabricante · San Clemente, CA 92672-7538
✎ GovInfoNow plain-language explainer

Pacific Medical is recalling ultrasound transducers M1356A that may have been serviced with non-OEM parts between December 2014 and April 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and maternal health, potentially delaying detection of distress. Read more at govinfonow.com/recall/67027-pacific-medical-ultrasound-transducer-m1356a-recall-risk-of-inaccurate-fetal.

Source Summary by GovInfoNow · govinfonow.com/recall/67027-pacific-medical-ultrasound-transducer-m1356a-recall-risk-of-inaccurate-fetal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1164-2020

Cite this page

“Pacific Medical Ultrasound Transducer M1356A Recall: Risk of Inaccurate Fetal Monitoring.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67027-pacific-medical-ultrasound-transducer-m1356a-recall-risk-of-inaccurate-fetal. Based on FDA recall #Z-1164-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2020%22&limit=1).

Pacific Medical Group Inc. recalled Ultrasound Transducers (M1356A) serviced with non-OEM components, the FDA said on Sept. 11, 2019. The agency announced the voluntary Class II recall due to risks of inaccurate fetal heart rate detection and patient burns.

How to tell if you have it

  • Brand: Pacific Medical
  • Product: Ultrasound Transducer (M1356A)
  • Serviced with: Pacific Medical Philips M1356A Ultrasound Board (NFPH9510), Bottom Case (NFPH9515), Cable Assembly (NFPH9520), or Crystal (NFPH9535)
  • Serial numbers serviced between 12/18/14 and 4/2/19
  • Units affected: 1994

The hazard

The devices were serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. This may cause inability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, and blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

Context

GovInfoNow's records show Pacific Medical Group Inc. has two other recalls on record since Sept. 19, 2019. On March 24, 2021, the company recalled Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel due to risk of free flow or under infusion. On Sept. 19, 2019, Pacific Medical Group recalled GE Corometrics Ultrasound Transducers for distribution before 510(k) clearance. Other recent recalls of similar products include Philips Avalon Fetal Monitor Recall: Incorrect Speaker Connector Risk (May 26, 2026) and LH One Step Ovulation Test Device Recall: False Results Risk Medical Errors (Nov. 22, 2025).

How to tell if you have this one

Check if your ultrasound transducer has the model M1356A and was serviced between December 18, 2014, and April 2, 2019. Look for serial numbers that match the service dates listed in the recall.

  • Brand
    Pacific Medical
  • Category
    Medical device
FDA recall event · 10 products

All 10 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
    Worldwide Distribution - US Nationwide in the states of::NH, NY, MN, PA, FL, AZ, LA, GA, IL, HI, CA, OR, SC, OH, NC, IA, OK, AL, MA, MD, WI, MI, AR, WA, SD, NV, KY, TX, MS, DE, NJ, NE, WV, MT, TN, VA, MO, VT, CO, CT, ME, WY, IN, UT, NM, AK, DC, ID, KS, ND, RI, NH. OUS: BEL, ARE, MEX, CAN, CYM, KOR, ZAF, BHR, ESP, ITA, FRA, VUT, AUS, GBR.
Recall numberProduct, codes & lotsQuantity
Z-1159-2020Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325; All serial numbers serviced between 4/13/15 and 4/2/19.9679
Z-1160-2020Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325; All serial numbers serviced between 1/19/15 and 4/2/1910911
Z-1161-2020Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535; All serial numbers serviced between 10/20/14 and 4/2/19.6481
Z-1162-2020Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535; All serial numbers serviced between 12/18/14 and 4/2/19.6797
Z-1163-2020External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340; All serial numbers serviced between 10/20/14 and 4/2/19.1603
Z-1164-2020Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535; All serial numbers serviced between 12/18/14 and 4/2/19.1994
Z-1165-2020Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341; All serial numbers serviced between 9/2/15 and 4/2/19.466
Z-1166-2020Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341; All serial numbers serviced between 9/2/15 and 4/2/19.2170
Z-1167-2020Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515; All serial numbers serviced between 9/2/15 and 4/2/19.5897
Z-1168-2020Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B; All serial numbers serviced between 9/2/15 and 4/2/19.1776
Based on the official FDA remedy

What to do — step by step

  1. Check Device Service History

    Review your device's service records to see if it was serviced between December 18, 2014, and April 2, 2019.

  2. Contact Manufacturer

    Reach out to Pacific Medical Group Inc. to confirm if your device is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of::NH, NY, MN, PA, FL, AZ, LA, GA, IL, HI, CA, OR, SC, OH, NC, IA, OK, AL, MA, MD, WI, MI, AR, WA, SD, NV, KY, TX, MS, DE, NJ, NE, WV, MT, TN, VA, MO, VT, CO, CT, ME, WY, IN, UT, NM,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

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

1. Firm started the recall: Sep 11, 201912. FDA classified it Class II: Feb 12, 202023. Published in FDA’s Enforcement Report: Feb 19, 2020320192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1164-2020 (September 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1164-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA