Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The Recalled by Datex-Ohmeda, Inc. Due to Potential for the display processor to experience an...
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
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: 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 CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.
Quantity: 349 (US) + 2,051 (OUS)
Why Was This Recalled?
Potential for the display processor to experience an unexpected failure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report