Class II — Potential Health Hazard

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

CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor Recalled by GE Healthcare, LLC Due to The oxygen sensor for certain CARESCAPE R860 devices...

Date: July 14, 2020
Company: GE Healthcare, LLC
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 GE Healthcare, LLC directly.

Affected Products

CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.

Quantity: 2277 units

Why Was This Recalled?

The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.

Where Was This Sold?

Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

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