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FDAFDA · Food and drugs·Recall number Z-1783-2014

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

Published June 18, 2014 · Recall initiated: March 5, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Healthcare Inc.
Distributor
Worldwide Distribution: US (nationwide) and country of: Canada.
Lot
All iX versions with A.01 software
Risk classification
Class II
Area (FDA)
device
Country
United States

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