RecallDepth

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

This recall has been terminated (originally issued January 24, 2006).

Company
Datascope Corp.
Recall Initiated
December 7, 2005
Posted
January 24, 2006
Terminated
August 1, 2006
Recall Number
Z-0437-06
Quantity
110 sites
Firm Location
Mahwah, NJ
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.

Lot / Code Info

All Panorama Central Station containing software versions 8.1.6 - 8.2

Root Cause

Other

Action Taken

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.

More recalls by Datascope Corp.

View all recalls by this company →