Recall Z-1401-2009 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc., dba Datascope Patient Monitoring
Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.
| Date | May 27, 2009 (initiated Apr 10, 2009) |
| Status | Terminated |
| Reason | Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system. |
| Root cause | Software design |
| Action | Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer. |
| Quantity | 294 sites |
| Distribution | Worldwide Distribution -- USA and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp., Oct 10, 2003 |