FDA Device recall Z-0980-2020
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
- 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 Toco Transducer w/wing (2264LAX), FFCM3260 by Pacific Medical Group, citing fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0980-2020 |
| 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 Toco Transducer w/wing (2264LAX), FFCM3260
Reason
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.
Identifiers
| code_info | All serial numbers distributed between 02/06/16 - 04/30/19. |
|---|
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-0980-2020%22
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