GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.
FDA Recall Z-0784-2007 · Posted 2007-05-10
Recalling FirmDatex - Ohmeda, Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-02-02
Date Terminated2008-10-16
Product Quantity446
Reason for Recall
There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
Firm Action
Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.
Root Cause
Other
Distribution Pattern
GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY.
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.