Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
This recall has been terminated (originally issued August 6, 2005).
- Company
- Datascope Corp.
- Recall Initiated
- June 16, 2005
- Posted
- August 6, 2005
- Terminated
- October 5, 2005
- Recall Number
- Z-1104-05
- Quantity
- 70 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
Distribution
There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
Lot / Code Info
All units currently out in the market.
Root Cause
Other
Action Taken
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.
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