Recall Z-1007-04 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Medical Inc.
Ultraview Universal Clinical Workstation Model 90385.
| Date | Jul 20, 2004 (initiated May 7, 2004) |
| Status | Terminated |
| Reason | Potential for telemetry channels to drop off display. |
| Root cause | Other |
| Action | For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004. |
| Quantity | 142 units |
| Distribution | The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.