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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia Elition X

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  Class 2 Device Recall Ingenia Elition X see related information
Date Initiated by Firm January 06, 2022
Date Posted February 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0974-2024
Recall Event ID 93737
510(K)Number K173356  K173451  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Code Information UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact Customer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		 Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
FDA Determined
Cause 2		 Device Design
Action Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023.
Quantity in Commerce 2
Distribution Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
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