Recall Z-0463-2019— GE Healthcare, LLC

Name: FDA recall Z-0463-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-05

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2018-10-05, terminated 2024-04-29. It names one FDA 510(k) clearance: K142679. Product: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) 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.. Reason: The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2018-10-05
Terminated: 2024-04-29
Firm location: Waukesha, 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

GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) 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.

Reason for recall

The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.

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