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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Engstrom Carestation

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 Class 2 Recall
GE DatexOhmeda Engstrom Carestation
see related information
Date Posted September 24, 2008
Recall Status1 Open
Recall Number Z-1829-2008
Recall Event ID 48080
Premarket Notification
510(K) Number
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.
Code Information Serial Number CBCL01134 CBCL01133 CBCL01128 CBCL01089 CBCL01087 CBCL01084 CBCL01075 CBCL01072 CBCL01070 CBCL01068 CBCL01067 CBCL01051 CBCL01050 CBCL01022 CBCL01021- CBCL01019 CBCL01018 CBCL01015 CBCL01012 CBCL01011 CBCL01010 CBCL01009 CBCL01008 CBCL01007 CBCL01000 CBCL00998 CBCL00997 CBCL00996 CBCL00995 CBCL00994 CBCL00993 CBCL00985 CBCL00984 CBCL00983 CBCL00978 CBCL00975 CBCL00974 CBCL00973 CBCL00972 CBCL00971 CBCL00968 CBCL00967 CBCL00966 CBCL00965 CBCL00964 CBCL00963 CBCL00962 CBCL00959 CBCL00958 CBCL00957 CBCL00956 CBCL00955 CBCL00954 CBCL00953 CBCL00952 CBCL00951 CBCL00950 CBCL00949 CBCL00948 CBCL00947 CBCL00946 CBCL00945 CBCL00944 CBCL00943 CBCL00942 CBCL00941 CBCL00940 CBCL00939 CBCL00938 CBCL00937 CBCL00936 CBCL00935 CBCL00934 CBCL00933 CBCL00932 CBCL00931 CBCL00930 CBCL00929 CBCL00928 CBCL00927 CBCL00926 CBCL00925 CBCL00924 CBCL00923 CBCL00922 CBCL00916 CBCL00915 CBCL00914 CBCL00913 CBCL00912 CBCL00911 CBCL00910 CBCL00909 CBCL00908 CBCL00907 CBCL00906 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Recalling Firm/
GE Healthcare
9900 Innovation Drive
Wauwatosa, Wisconsin 53226
Manufacturer Reason
for Recall
There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation. This issue affects all of the Engstr¿m Carestations shipped between 12/4/2006
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were sent a "GE Urgent Medical Device Correction" letter on 5/12/08 addressed to Health Care Administrator/Risk Manger, Chief of Intensive Care & Director of Clinical Engineering. The letter described the affected product and the problem and provided a short term recommendation and a long term solution which included installation of a revised board on all affected Engstrom Carestations. A GE Healthcare Field Service Engineer to contact the facility to schedule the update. If you have questions, contact Melissa Davis at GE Healthcare at 1-800-345-2700 extension 3439.
Quantity in Commerce 1130
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DATEX-OHMEDA, INC.