Company: Datascope Corp
Date of Enforcement Report: 8/17/05
Class: II

PRODUCT
Panorama Patient Monitoring Network Cardiac Arrhythmia Monitor, Recall # Z-1104-05

REASON
Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.

CODE
All units on the market

RECALLING FIRM
Datascope Corp, Mahwah, NJ, by letter on June 10, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
70 units

DISTRIBUTION
Nationwide, Belgium and Italy