Recall Z-1104-05 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Datascope Corp
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
| Date | Aug 6, 2005 (initiated Jun 16, 2005) |
| Status | Terminated |
| Reason | Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages. |
| Root cause | Other |
| 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. |
| Quantity | 70 units |
| Distribution | There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp., Oct 10, 2003 |