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.
FDA Recall Z-1829-2008 · Posted 2008-09-24
Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-04-23
Date Terminated2012-05-16
Product Quantity1130
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 Engstrm Carestations shipped between 12/4/2006
Firm 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.
Root Cause
Device Design
Distribution Pattern
WI, GA, SC, TX, RI, NY, NM, IN VIETNAM, VENEZULA, UNITED KINGDOM, TURKEY, KOREA, JAPAN, ITALY, INDIA, ICELAND, HONG KONG, GREECE, GERMANY, GEORGIA, FRANCE, TUNISIA, THAILAND, SWITZERLAND, SPAIN, SOUTH AFRICA, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CANADA, BRAZIL, BELGIUM, BANGLADESH, BAHRAIN, SLOVENIA, SINGAPORE, SAUDI, RUSSIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, NETHERLAND,MOROCCO, MEXICO, MAYLASIA, LYBIA, LEBANON, KUWAIT, AUSTRIA, AUSTRALIA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.