CLASS II ONGOING Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Ultrasound Transducer (M2736A) recalled by Pacific Medical Group

Pacific Medical Group is recalling Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific, distributed nationwide in the US. The recall was initiated on 11 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers serviced between 9/2/15 and 4/2/19.

Quantity recalled5897

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-1167-2020
FDA event ID: 83610
Recalling firm: Pacific Medical Group, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2019
FDA classified: 12 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Imaging Equipment

Timeline

11 Sep 2019	Recall initiated by company
12 Feb 2020	Classified by FDA	+154 days
19 Feb 2020	Published in enforcement report	+7 days

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

Reason for recall

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Ultrasound 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

Where it was distributed

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.

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

Questions about this recall

Is Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific recalled?

Yes. Pacific Medical Group recalled Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific on 11 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-1167-2020.

Why was it recalled?

Which lots are affected?

All serial numbers serviced between 9/2/15 and 4/2/19.

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	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
19 Feb 2020Device	CLASS II	Loop-Style Ultrasound Transducer (Nautilus) recalled	Pacific Medical Group	Temperature Abuse	Nationwide

Other Imaging Equipment recalls

All 2,336

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9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
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2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals