Z-0980-2020Class II

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

Name: Z-0980-2020 Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Creator: Pacific Medical Group Inc.
Published: 2019-09-19
License: https://open.fda.gov/license/

Pacific Medical Group Inc. / initiated 2019-09-19 / Open, Classified

FDA source

Pacific Medical Group Inc. began a recall of Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 on 2019-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0980-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-19
Posted: 2020-02-04
Recalling firm: Pacific Medical Group Inc.
Product: Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Product code: HFM Monitor, Uterine Contraction, External (For Use In Clinic)
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.
FDA root cause: No Marketing Application
Action: On 09/19/19, Urgent Medical Device Recall notices were emailed to customers informing them of the following possible failures associated with the post market events: - Fluid damage/intrusion, solder cracks, component failure. - Damaged membrane or cracked case. - Internal short from usage, broken connector from misuse. - Broken leads, loose coil. - Loose crystal from failure of adhesive, internal short or improper grounding. - Miscalibration of the device/waveform. - Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not function properly without intact components. If wave forms are not capturing the clinical data including fetal heart rate, oxygen saturation, patient's temperature or uterine activity, the device should not be used. Immediate actions to be taken by the Customer/User: - Inspect the device before each use to observe for any signs of device damage including cracked case, broken leads, loose coils, or damaged components and immediately remove the device from clinical service. - If any fluid intrusion is noted, remove the device from service immediately. - Any signs that the device is overheating should be recognized as a potential serious issue and should not be used and/or removed from the patient immediately. - If waveforms are not capturing on the monitor or there is artifact, this may be due to miscalibration of the device or a component malfunction. Remove the device from service. You may continue to utilize the affected devices as the recalling firm reasonably believes use of, exposure to, the affected products is not likely to cause adverse health consequences. Complete and return the customer acknowledgement form to the recalling firm. If you have subsequently resold or distributed the affected product, please ensure that this information is provided to your customer(s). Customers with additional questions or complaints are encouraged to call (800) 449-5328.
Quantity in commerce: 628
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. (Foreign): CA, CO, FR, GB, IT, MX, UAE
Product codes and lots: All serial numbers distributed between 02/06/16 - 04/30/19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0980-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0981-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0982-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0983-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0984-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0985-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code HFM

K012718Class IIModification to Corometrics Model 120Is Maternal/fetal Monitoring System.Ge Medical Systems Information Technologies / cleared 2001-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)