Device recall: Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Class II FDA enforcement event 83869. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Medical Group Inc. started this device recall on 19 Sep 2019. The firm address in the FDA record is in San Clemente, CA. FDA put the recall in Class II. FDA event 83869 has 7 product records. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.…
Recalling firm
Pacific Medical Group Inc., San Clemente, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0979-2020 | Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 | 772 | Class II | Ongoing | 12 Feb 2020 |
| Z-0980-2020 | Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 | 628 | Class II | Ongoing | 12 Feb 2020 |
| Z-0981-2020 | Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 | 295 | Class II | Ongoing | 12 Feb 2020 |
| Z-0982-2020 | Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 | 4 | Class II | Ongoing | 12 Feb 2020 |
| Z-0983-2020 | Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 | 678 | Class II | Ongoing | 12 Feb 2020 |
| Z-0984-2020 | Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 | 261 | Class II | Ongoing | 12 Feb 2020 |
| Z-0985-2020 | Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 | 225 | Class II | Ongoing | 12 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 7
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Mar 2021 | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health So | Device | Class I | 1 |
| 11 Sep 2019 | Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Med | Device | Class II | 10 |
Official channels
- FDA enforcement report Z-0979-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 83869. https://recallregister.com/fda/ii/83869/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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.…
- What quantity of product is in FDA event 83869?
- The event has 7 product records. The first record gives this quantity:
772
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.