# FDA recall Z-2640-2017

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2016-04-04.

## 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.

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2640-2017
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-04-04
- **Report date:** 2017-07-05
- **Termination date:** 2019-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hartland, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2017

## Citation

> AI Analytics. FDA recall Z-2640-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2640-2017. Source: US FDA. Licensed CC0.

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