Z-1783-2014Class II

Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC...

Name: Z-1783-2014 Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC...
Creator: Philips Healthcare Inc.
Published: 2013-03-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-03-05 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor on 2013-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1783-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-05
Posted: 2014-06-11
Terminated: 2017-05-17
Recalling firm: Philips North America LLC
Product: Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA 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 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: US (nationwide) and country of: Canada.
Product codes and lots: All iX versions with A.01 software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1783-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1783-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-11

Product code MHX

K102495Class IIM3290b Intellivue Information Center Software, Release A.0Philips Medical Systems / cleared 2010-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)