Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Neonatal Flow Sensor Cable used on devices CARESCAPE R860 Recalled by Datex-Ohmeda, Inc. Due to The Neonatal Flow Sensor Cable may be missing...

Date: June 28, 2018
Company: Datex-Ohmeda, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Datex-Ohmeda, Inc. directly.

Affected Products

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.

Quantity: 417 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report