The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2738-2018·Announced 2018-08-15

Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing

Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a defect that exposes electrical wires, posing a risk of electrical shock or fire. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk structural defects in medical devices, warranting a Severe classification.

Plain-English summary

Datex-Ohmeda, Inc. is recalling 417 units of the Neonatal Flow Sensor Cable used with CARESCAPE R860, ENGSTROM CARESTATION, and ENGSTROM PRO ventilators. The recall also covers cables contained in Neonatal Software Upgrade Kit 2080496-010. The affected cables are identified by specific model and serial numbers listed in the official recall notice.

The recall is being issued because the connector housing on the cable may be missing, which exposes the wires inside the cable. This defect creates a risk of electrical shock or fire. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Africa, Asia, Europe, and the Americas. Healthcare facilities and consumers should check their equipment for the specific model and serial numbers listed in the recall notice. If the cable is affected, it should be removed from service immediately and the manufacturer contacted for instructions on replacement or repair.

The recalled product

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…
Manufacturer
Datex-Ohmeda, Inc.
Category
Medical Device — Ventilator Accessories
Hazard
Affected units
417

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Number1506-8600-000

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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