Recall Z-2266-2018— Datex-Ohmeda, Inc.

Name: FDA recall Z-2266-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-08

Class II · Terminated

Class II FDA medical device recall by Datex-Ohmeda, Inc., initiated 2017-12-08, terminated 2021-04-29. It names one FDA 510(k) clearance: K142679. Product: 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.. Reason: Potential for the display processor to experience an unexpected failure..

Recalling firm: Datex-Ohmeda, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Terminated: 2021-04-29
Firm location: Madison, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K142679 — CARESCAPE R860Datex-Ohmeda, Inc.·cleared 2015-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential for the display processor to experience an unexpected failure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.