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Pacific Medical Group Recalls
18 recalls on record · February 12, 2020 to April 28, 2021 · Medical Devices
Recalls by year
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 28, 2021Medical DevicesFDA
Pacific Medical Group Inc. recalls Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health So
Hazard: Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philip
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasoun
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco B
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacifi
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Paci
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Coromet
Hazard: 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.
February 19, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Med
Hazard: 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.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Hazard: 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.
February 12, 2020Medical DevicesFDA
Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Hazard: Fetal transducers distributed in advance of receiving 510(k) and international clearances.