Company: Datascope Corp.
Date of Enforcement Report 2/1/2006
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06
Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
All Panorama Central Station containing software versions 8.1.6 through 8.2
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Datascope Corp., Mahwah, NJ, by letters on December 7, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE