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.
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