# FDA recall Z-0980-2020

> **Pacific Medical Group Inc.** · Class II · device recall initiated 2019-09-19.

## Product

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

## 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.

## 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

## Key facts

- **Recall number:** Z-0980-2020
- **Recalling firm:** Pacific Medical Group Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-19
- **Report date:** 2020-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0980-2020

## Citation

> AI Analytics. FDA recall Z-0980-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0980-2020. Source: US FDA. Licensed CC0.

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