Recall Z-0980-2020— Pacific Medical Group Inc.
Class II · Ongoing
Class II FDA medical device recall by Pacific Medical Group Inc., initiated 2019-09-19. It names one FDA 510(k) clearance: K012718. 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..
- Recalling firm
- Pacific Medical Group Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-19
- Firm location
- San Clemente, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.