Company: Datex-Ohmeda, Inc.
Date of Enforcement Report 6/27/2018
Class II:
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. Recall Number: Z-2266-2018
REASON
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms..
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc. on 12/8/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
349 (US) + 2,051 (OUS)
DISTRIBUTION
Nationwide and Internationally