Recall Z-2703-2017— GE Healthcare, LLC

Name: FDA recall Z-2703-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-02

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-05-02, terminated 2018-02-13. It names one FDA 510(k) clearance: K151570. Product: Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1. Reason: Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-05-02
Terminated: 2018-02-13
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 A1, Carestation 650 A1, and Carestation 650c A1

Reason for recall

Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

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