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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 August 16, 2008
Recall Status1 Open
Recall Number Z-1526-2008
Recall Event ID 44927
Premarket Notification
510(K) Number
K062710 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Datex - Ohmeda, Inc
Po Box 7550
Madison, Wisconsin 53707
Manufacturer Reason
for Recall
Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstr¿m Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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.
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.
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