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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntellVue Info Center

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 Class 2 Recall
Philips IntellVue Info Center
see related information
Date Posted June 11, 2014
Recall Status1 Open
Recall Number Z-1783-2014
Recall Event ID 64507
Premarket Notification
510(K) Number
K102495 
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
Product Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Code Information All iX versions with A.01 software
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIX iX software resolving this issue on affected units. Philips will conduct these updates for all affected devices at no charge.
Quantity in Commerce 899
Distribution Worldwide Distribution to US, Canada, and International
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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