Z-0374-2016Class II

Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023...

Name: Z-0374-2016 Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023...
Creator: Philips Medical Systems, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-12-19 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade... on 2014-12-19. FDA classified it as Class II and gives the reason as "Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification". 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-0374-2016
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-12-04
Terminated: 2020-09-21
Recalling firm: Philips North America LLC
Product: Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm, Philips Healthcare, issued a "URGENT-Field Safety Notice" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from Optional to Hidden 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. If you need any further information or support concerning this issue, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
Quantity in commerce: 10,013 units
Distribution: Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Product codes and lots: Software systems Revision A.02.05 or lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0374-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0374-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)