Merge Healthcare, Inc. recalls SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics moni…

Recall date

April 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2640-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.