# FDA recall Z-0982-2020

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

## Product

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

## Reason for recall

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

## 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-0982-2020
- **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-0982-2020

## Citation

> AI Analytics. FDA recall Z-0982-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0982-2020. Source: US FDA. Licensed CC0.

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