Class 2 Device Recall GE DatexOhmeda Engstrom Carestation

• Date Initiated by Firm: July 02, 2007
• Date Posted: August 16, 2008
• Recall Status: Terminated on July 03, 2012
• Recall Number: Z-1526-2008
• Recall Event ID: 44927
• 510(K)Number: K062710
• Product Classification: Ventilator - 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 WI 53707
• For Additional Information Contact: 262-312-7700
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK