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Merge Healthcare, Inc. recalls SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics m
Recalled July 5, 2017 · FDA recall Z-2640-2017 · 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
219 cables
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
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 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 →