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Merge Healthcare, Inc. recalls MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: M
Recalled July 5, 2017 · FDA recall Z-2643-2017 · Merge Healthcare
Hazard
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. · FDA Class II
Units
65 sensors
Sold at
Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
Description
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.
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 for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →