Z-0495-2013Class II

Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of...

Name: Z-0495-2013 Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of...
Creator: Philips Healthcare Inc.
Published: 2012-11-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-11-09 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display... on 2012-11-09. FDA classified it as Class II and gives the reason as "Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms". 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-0495-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Posted: 2012-12-10
Recalling firm: Philips North America LLC
Product: Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX 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. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. 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: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 3165
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421 M3170 Patient Link 865416 M3177 Trend Display 865422 M3140 Upgrade 865423 M3150 Upgrade 865426 M3145 Upgrade 865427 M3155 Upgrade 865424 M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267 M3150 Information Center Local DB 865269 M3145 Information Center Small NW DB 865268 M3155 Information Center NW DB 865270 M3151 Information Center Client 865274 M3170 Patient Link 865271 M3177 Trend Display 865277 M3140 Upgrade 865278 M3150 Upgrade 865281 M3145 Upgrade 865282 M3155 Upgrade 865279 M3151 Upgrade PIIC iX 866023 IntelliVue Info Center iX 866117 PIIC Classic Upgrade 866027 PIIC iX HW Upgrade

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0495-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0495-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10

Product code MHX

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)