Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill.
May result in the inability to access certain menu functions which could possibly lead to delay in treatment.
GE Healthcare has initiated a voluntary field corrective action for the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines due to a potential safety issue. The affected units were manufactured between the dates of April 23, 2013 and July 22, 2013.
GE Healthcare has initiated a voluntary field corrective action for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. The affected units were manufactured from February 2011 through July 2013.
A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.
Facilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system