Class 2 Device Recall Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software

• Date Initiated by Firm: May 05, 2014
• Create Date: October 19, 2015
• Recall Status: Terminated on June 14, 2016
• Recall Number: Z-0135-2016
• Recall Event ID: 68228
• 510(K)Number: K110151 K063559
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
• Code Information: All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 800-722-9377
• Manufacturer Reason for Recall: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
• FDA Determined Cause: Software design
• Action: Consignees were notified of the recall by letter sent May 2014. They were instructed to do the following: Do not perform planning or review planning of transversal images on fused sagittal images which were generated through Mobi View postprocessing Instead, review the planning of transversal scans only on the unfused stations. A Field Change Order with reference FC0781 00431 is being released that PHILIPS requires Philips field service engineers to disable the MobiView post processing software. When possible this will be done remotely. Once it becomes available, a software update will be installed which will address the reference line positioning issue with MobiView Should you need to communicate with Philips with regard to this program, please reference FC0781 00431. If you need any further information or support concerning this issue, please contact your local Philips representative or the Technical Support Line: 1-800-722-9377.
• Quantity in Commerce: 317
• Distribution: Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates 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 = LNH and Original Applicant = PHILIPS HEALTHCARE; 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS