FDA Device

Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.

Hazard

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

What You Should Do

Remedy

The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.

Products

Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
Brand
Datascope Corp
UPC
All units currently out in the market.

Units Affected

70 units