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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products)

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  Class 2 Device Recall Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) see related information
Date Initiated by Firm May 15, 2014
Date Posted June 18, 2014
Recall Status1 Terminated 3 on August 07, 2015
Recall Number Z-1826-2014
Recall Event ID 68311
510(K)Number K110151  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products)

Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
Code Information Model Numbers: 9896 030 1929.2, 9896 030 1929.3 
Recalling Firm/
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
FDA Determined
Cause 2
Device Design
Action Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping. For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
Quantity in Commerce 420
Distribution Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
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