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.
Recall
- Recall Number
- Z-2640-2017
- Event Number
- 76974
- Firm
- Merge Healthcare, Inc.
- FEI Number
- 1000116130
- Product Code
- DQK
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- April 4, 2016
- Terminated
- October 15, 2019
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347
Description
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.
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.
Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the affected product problem and actions to be taken.
Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
219 cables