BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice for Infinity Delta, Delta XL, Vista XL, Gamma XXL and Kappa patient monitors, Draeger Medical Systems, Inc.

Product group Medical electronics / Electromedical devices
Reference 04946/11

Dräger has issued a Field Safety Notice on a problem in conjunction with the patient monitor and the Masimo SET pod used for SpO2 measurement. Ventricular fibrillation arrhythmias will not be recognized and there is no alarm sounding.
The affected software versions are VF6.2, VF6.3, VF6.4, VF7.1, and VF7.2. This issue has been corrected in software versions VF7.3 and higher.

Safety Notice for Infinity Delta, Delta XL, Vista XL, Gamma XXL and Kappa patient monitors, Draeger Medical Systems, Inc. , Download_VeroeffentlichtAm_EN PDF, 271KB, File does not meet accessibility standards