Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
Hazard
Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.
What You Should Do
Firm initiated their recall of this device on October 25, 2011 by sending an "Urgent Medical Device Recall" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.
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Products
- Brand
- Draeger Medical, Inc.
- UPC
- Catalog Number(s): MS18597 and MS18852, Software versions: VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2
Units Affected
14,894