FDAnews Device Daily Bulletin

China Department of Health Issues Recall for Device Software

Oct. 25, 2011
The Chinese Department of Health has issued a recall for Draeger Medical Hong Kong’s Delta, Delta XL, Vista XL, Gamma XXL and Kappa with software version VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2 because ventricular fibrillation arrhythmias will not be recognized by the monitor and will not alarm when the Masimo SET pod is used for SpO2 measurements.