Datascope Corp. Class II

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.