Recall Z-1162-2020— Pacific Medical Group Inc.

Name: FDA recall Z-1162-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-11

Class II · Ongoing

Class II FDA medical device recall by Pacific Medical Group Inc., initiated 2019-09-11. It names one FDA 510(k) clearance: K012718. Product: Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535. Reason: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. 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 delay in detecting maternal or fetal distress..

Recalling firm: Pacific Medical Group Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-09-11
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K012718 — MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.Ge Medical Systems Information Technologies·cleared 2001-11-13

K-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

Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

Reason for recall

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. 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 delay in detecting maternal or fetal distress.

Data sourced from openFDA. This site is unofficial and independent of the FDA.