Class 2 Device Recall Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software

• Date Initiated by Firm: April 02, 2014
• Date Posted: April 24, 2014
• Recall Status: Terminated on June 16, 2016
• Recall Number: Z-1495-2014
• Recall Event ID: 67868
• 510(K)Number: K072960
• Product Classification: System, image processing, radiological - Product Code LLZ
• 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
• Code Information: Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-687-1501
• Manufacturer 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
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ and Original Applicant = CDP, LTD.