Company: Draeger Medical, Inc.
Date of Enforcement Report: 7/16/03
Class: II

PRODUCT
Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03.

REASON
Software problems – ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

CODE
Software version 4.00 or 4.10.

RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letters dated May 7, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
806 units.

DISTRIBUTION
Nationwide, and Canada.