Z-1495-2014Class II

Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving...

Name: Z-1495-2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving...
Creator: Philips Medical Systems, Inc.
Published: 2014-04-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-04-02 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording... on 2014-04-02. FDA classified it as Class II and gives the reason as "Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations". 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-1495-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Posted: 2014-04-24
Terminated: 2016-06-16
Recalling firm: Philips North America LLC
Product: Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent a Urgent Medical Device Correction Notification/Field Safety Notice dated March 2014, to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace the software free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Until you receive a software upgrade from Philips, the user must configure the MRI and CT devices to send regular CT or MR DICOM image objects (not enhanced) to PACS.. This issue does not affect images that are not enhanced image objects. Further questions please call (978) 687-1501.
Quantity in commerce: 373 units
Distribution: Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code LLZ

K072960Class IICdp 5000, Media and Distribution Center, DiagnetCdp, Ltd. / cleared 2007-11-08

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)