FDA Device

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

Hazard

Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

What You Should Do

Remedy

Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.

Products

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Brand
Datascope Corp
UPC
All Panorama Central Station containing software versions 8.1.6 - 8.2

Units Affected

110 sites