Recall Z-0776-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
| Date | Jan 3, 2018 |
| Status | Terminated |
| Reason | Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018. |
| Root cause | Software design |
| Action | To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged. Philips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th. A Philips Hea |
| Quantity | 20357 |
| Distribution | Domestic and Foreign |
| FDA record | Open on fda.gov |