Philips Medical Systems, Inc. recalls Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing

Recalled April 30, 2014 · FDA recall Z-1495-2014 · Philips Medical Systems

Hazard

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

Units

373 units

Sold at

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.

Description

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

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

Manufacturer(s)

Philips Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →