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

Pacific Medical Philips M1356A Ultrasound Transducer recalled

Pacific Medical Group is recalling Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250, 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 recalled225

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-0985-2020
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 Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

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

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

Other products in this recall event

6 other products · FDA event 83869

This product is part of a recall event; the main page for the event is Pacific Medical GE Corometrics Nautilus Ultrasound recalled.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020	CLASS II	Pacific Medical GE Corometrics Nautilus Ultrasound recalled	Pacific Medical Group	Other	45 states
12 Feb 2020	CLASS II	Pacific Medical GE Corometrics Nautilus Ultrasound recalled	Pacific Medical Group	Other	45 states
12 Feb 2020	CLASS II	Pacific Medical Philips M1355A Toco Transducer recalled	Pacific Medical Group	Other	45 states
12 Feb 2020	CLASS II	Pacific Medical GE Corometrics Nautilus Toco Transducer recalled	Pacific Medical Group	Temperature Abuse	45 states
12 Feb 2020	CLASS II	Pacific Medical GE Corometrics Nautilus Toco Transducer recalled	Pacific Medical Group	Other	45 states
12 Feb 2020	CLASS II	Pacific Medical GE Corometrics Nautilus Ultrasound recalled	Pacific Medical Group	Other	45 states

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	Device Malfunction	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

Other Imaging Equipment recalls

All 2,336

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2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
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 Nederl	Potency & Assay