Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
FDA Recall Z-1104-05 · Posted 2005-08-06
Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeDRT
Date Initiated2005-06-16
Date Terminated2005-10-05
Product Quantity70 units
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.