FDA Device recall Z-0982-2020
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
- FDA Device
- Class II
- ongoing
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 by Pacific Medical Group, citing fetal transducers distributed in advance of receiving 510(k) and international clearances.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0982-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-19 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pacific Medical Group |
| Distribution | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
Product
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Reason
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Identifiers
| code_info | All serial numbers sold between 01/21/2015 - 04/30/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0982-2020%22
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