Recall Z-1783-2014— Philips Healthcare Inc.

Name: FDA recall Z-1783-2014
Creator: U.S. Food and Drug Administration
Published: 2013-03-05

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-03-05, terminated 2017-05-17. It names one FDA 510(k) clearance: K102495. Product: Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.. 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..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-05
Terminated: 2017-05-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0Philips Medical Systems·cleared 2010-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.