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Recall Observatory FDA recall evidence

Device product

Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

Z-1783-2014

March 05, 2013

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 64507
Status
Terminated
Classification
Class II
Quantity
899
Official record key
device-enforcement:Z-1783-2014

Official wording

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.

Code information: All iX versions with A.01 software

Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.