RecallDepth

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

This recall has been terminated (originally issued September 21, 2005).

Company
Datascope Corp.
Recall Initiated
August 19, 2005
Posted
September 21, 2005
Terminated
June 21, 2006
Recall Number
Z-1567-05
Quantity
115 units
Firm Location
Mahwah, NJ
Official Source
View on FDA website ↗

Reason for Recall

The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.

Distribution

The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.

Lot / Code Info

Part Number 0040-00-0366-20.

Root Cause

Other

Action Taken

A recall letter was sent to the consignees on 8/19/2005.

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