Recall Z-1567-05 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Datascope Corp
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
| Date | Sep 21, 2005 (initiated Aug 19, 2005) |
| Status | Terminated |
| Reason | The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse. |
| Root cause | Other |
| Action | A recall letter was sent to the consignees on 8/19/2005. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp., Oct 10, 2003 |