FDA Device recall Z-0981-2020
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
- 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 Transducer w/knob, 5700HAX, FFCM5205 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-0981-2020 |
| 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 Transducer w/knob, 5700HAX, FFCM5205
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-0981-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.