Recall Z-0579-2018— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-0579-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-11

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2017-10-11. It names one FDA 510(k) clearance: K151570. Product: Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1. Reason: Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2017-10-11
Firm location: Wuxi, China

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

Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

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