Z-1526-2008

GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O...

Name: Z-1526-2008 GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O...
Creator: Datex - Ohmeda, Inc
Published: 2007-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-07-02 / Terminated / root cause: manufacturing process

FDA source

Datex - Ohmeda, Inc began a recall of GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to... on 2007-07-02. The reason FDA records is "Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1526-2008
Status: Terminated
Initiated: 2007-07-02
Posted: 2008-08-16
Terminated: 2012-07-03
Recalling firm: GE Healthcare
Product: GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent a Medical Device Correction Notification letter on July 2, 2007. The firm's short term recommendation is that Neonatal Flow Sensors may continue to be used with added viligance around potential patient circuit disconnections and the associated alarms. Ther firm recommends that the MV exp high and Circuit leak alarms be set appropriately for each patient in order to detect a patient disconnect. The long term recommendation was to order the replacement part when available and dispose of the old part when the replacement is received.
Quantity in commerce: 394
Distribution: Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates.
Product codes and lots: All serial numbers

Product code CBK

K062710Class IIGe Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. / cleared 2006-12-08

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)