Company: Datascope Corp.
Date of Enforcement Report: 9/28/05
Class:II
PRODUCT
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20, Recall # Z-1567-05
REASON
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
CODE
Version 8.02
RECALLING FIRM/MANUFACTURER
Datascope Corp, Mahwah, NJ, by letter on August 19, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
Nationwide and Internationally
