Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1495-2014

April 02, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 67868
Status
Terminated
Classification
Class II
Quantity
373 units
Official record key
device-enforcement:Z-1495-2014

Official wording

Reason: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations

Code information: Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations