Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1567-05

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor

Datascope Corp. / initiated 2005-08-19 / Terminated / root cause: software

Datascope Corp began a recall of Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor on . The reason FDA records is "The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1567-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Datascope Corp.
Product
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Reason for recall
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
Root cause tag
software
FDA root cause
Other
Action
A recall letter was sent to the consignees on 8/19/2005.
Quantity in commerce
115 units
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.
Product codes and lots
Part Number 0040-00-0366-20.