Drug recall
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
FDA recall event 83869 · Class II · Pacific Medical Group Inc.
Key facts
| Event ID | 83869 |
|---|---|
| Recall numbers | Z-0979-2020, Z-0980-2020, Z-0981-2020, Z-0982-2020, Z-0983-2020, Z-0984-2020, Z-0985-2020 |
| Recalling firm | Pacific Medical Group Inc. |
| Product type | Devices |
| Products | Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205, Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260, Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660, Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205, Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fetal transducers distributed in advance of receiving 510(k) and international clearances., 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… |
| Initiation date | Sep 19, 2019 |
| Report date | Feb 12, 2020 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 3007409280 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: