Datex Ohmeda, Inc 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

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