Z-2528-2017Class II

M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011...

Name: Z-2528-2017 M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011...
Creator: Philips Electronics North America Corporation
Published: 2010-12-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-12-17 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095... on 2010-12-17. FDA classified it as Class II and gives the reason as "Potential for early component failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2528-2017
Classification: Class II
Status: Terminated
Initiated: 2010-12-17
Posted: 2017-06-13
Terminated: 2017-08-01
Recalling firm: Philips North America LLC
Product: M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use 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: Potential for early component failure.
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips sent an Urgent Medical Device Correction letter dated December 17, 2010, to all affected consignees. Philips will replace defective system boards in Hewlett Packard model rp5700 PCs sold with IntelliVue Information Centers to correct the problem. Philips Healthcare representatives will inspect all affected units, and any unit identified to have a defective system board will have its system board replaced at no charge to the customer. Philips is asking the following of customers in the Action to be Taken by Customer/User section of the FSN: Observe your system for any of the symptoms described in the Problem Description section above. If symptoms are noted, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 # 3, # 1. Do not rely exclusively on the audible alarm system for patient monitoring. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. For questions regarding this recall call 978-659-3000.
Quantity in commerce: 607 units
Distribution: Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM
Product codes and lots: This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2528-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13

Product code MHX

K062271Class IIM3290a Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)Philips Medical Systems / cleared 2006-11-30

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)