The Recall Desk

FDA (Devices) recall action 76974

Merge Healthcare, Inc. recalled 4 products on 2017-07-05

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2017-07-05
Critical
0
Units
290

Why these products were recalled

Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2017-07-05

    Merge Healthcare Recalls MasimoSET SpO2 Sensors for Display Issues

    Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.

    Product
    MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is
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  • ModerateFDA (Devices)··2017-07-05

    Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

    Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

    Product
    Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital
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  • HighFDA (Devices)··2017-07-05

    Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors

    Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.

    Product
    SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring
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  • HighFDA (Devices)··2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
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