Recall Z-0437-06 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Datascope Corp
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
| Date | Jan 24, 2006 (initiated Dec 7, 2005) |
| Status | Terminated |
| Reason | Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off. |
| Root cause | Other |
| Action | Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer. |
| Quantity | 110 sites |
| Distribution | The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp., Oct 10, 2003 |