Recall Z-0813-2020— GE Healthcare, LLC

Name: FDA recall Z-0813-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-25

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-11-25, terminated 2023-11-30. It names one FDA 510(k) clearance: K151570. Product: Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.. Reason: GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2019-11-25
Terminated: 2023-11-30
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K151570 — Carestation 620/650/650CDatex-Ohmeda, Inc.·cleared 2016-01-21

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

Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

Reason for recall

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

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