Recall Z-0150-2008 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Datascope Corporation
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ
| Date | Jan 17, 2008 (initiated Oct 9, 2007) |
| Status | Terminated |
| Reason | Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced. |
| Root cause | Software design |
| Action | Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade. |
| Quantity | 338 sites |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.