# FDA recall Z-2738-2018

> **Datex-Ohmeda, Inc.** · Class II · device recall initiated 2018-06-28.

## Product

The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010.     The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

## Reason for recall

The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.

## Distribution

Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia,  Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands,  Nigeria, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, and Vietnam.

## Key facts

- **Recall number:** Z-2738-2018
- **Recalling firm:** Datex-Ohmeda, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-28
- **Report date:** 2018-08-15
- **Termination date:** 2019-02-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2018

## Citation

> AI Analytics. FDA recall Z-2738-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2738-2018. Source: US FDA. Licensed CC0.

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