Recall Z-1783-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Healthcare Inc.
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
| Date | Jun 11, 2014 (initiated Mar 5, 2013) |
| Status | Terminated |
| Reason | If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted. |
| Root cause | Software design |
| Action | On 3/5/13, Philips sent each known affected customer an Urgent Medical Device Correction notification/Field Safety Notice to inform them that Philips has received a customer report that the PIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. In order to prevent this from occurring, customers were advised to not modify/customize the default trend scales for reviewing stored patient data in the retrospective review applications. Recall letter also states that a Philips |
| Quantity | 899 |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 Philips Medical Systems, Sep 30, 2010 |