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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83869

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 19, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Pacific Medical Group Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

Z-0979-2020
Recall number
Z-0979-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
772

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All serial numbers sold between 02/06/2016 - 04/30/2019

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

device · product 2 of 7

Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

Z-0980-2020
Recall number
Z-0980-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
628

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances. 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 interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fetal transducers distributed in advance of receiving 510(k) and international clearances. 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 interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

Code information

All serial numbers distributed between 02/06/16 - 04/30/19.

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

device · product 3 of 7

Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205

Z-0981-2020
Recall number
Z-0981-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
295

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

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

device · product 4 of 7

Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

Z-0982-2020
Recall number
Z-0982-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

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

device · product 5 of 7

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

Z-0983-2020
Recall number
Z-0983-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
678

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

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

device · product 6 of 7

Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

Z-0984-2020
Recall number
Z-0984-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
261

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All serial numbers sold between 10/24/2014 - 04/30/2019

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

device · product 7 of 7

Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

Z-0985-2020
Recall number
Z-0985-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Quantity
225

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fetal transducers distributed in advance of receiving 510(k) and international clearances.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

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