Z-0784-2007

GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW...

Name: Z-0784-2007 GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW...
Creator: Datex - Ohmeda, Inc
Published: 2007-02-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-02-02 / Terminated

FDA source

Datex - Ohmeda, Inc began a recall of GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers... on 2007-02-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0784-2007
Status: Terminated
Initiated: 2007-02-02
Posted: 2007-05-10
Terminated: 2008-10-16
Recalling firm: GE Healthcare
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
FDA root cause: Other
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.
Quantity in commerce: 446
Distribution: 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.
Product codes and lots: Serial numbers: CBCH00101, CBCH00110, CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686, CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru CBCK00526, CBCK00535

Product code CBK

K060862Class IIGe Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. / cleared 2006-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)