Company:Draeger Medical, Inc
Date of Enforcement Report 12/8/11
Class ll:
PRODUCT
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). Catalog Number(s): MS18597 and MS18852. Recall # Z-0281-2012.
REASON
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..
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letter on October 25, 2011. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
14,894
DISTRIBUTION
Nationwide and Internationally