Class 2 Device Recall Intellispace Portal and Extended Brillance Workspace

• Date Initiated by Firm: May 23, 2012
• Date Posted: July 11, 2012
• Recall Status: Terminated on September 30, 2013
• Recall Number: Z-1987-2012
• Recall Event ID: 62005
• 510(K)Number: K060937 K012009 K033326
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: IntelliSpace Portal software and Extended Brillance Workspace software ; ; Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
• Code Information: Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Kumudini J. Carter; 440-483-7000
• Manufacturer Reason for Recall: The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
• FDA Determined Cause: Software design
• Action: Philips Healthcare sent a Urgent Medical Device Correction letter dated May 31, 2012, to all affected customers. The letter was sent via certified mail to each customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office at (1-800-722-9377 Option 5 : Entersite ID or follow the prompts). Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. The user was informed that a field service representative will visit the facility to install the new software. Philips apologizes for any inconveniences caused by this problem.
• Quantity in Commerce: 38
• Distribution: Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, 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 = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.