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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia

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 Class 2 Device Recall Ingeniasee related information
Date Initiated by FirmDecember 03, 2025
Date PostedJanuary 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1212-2026
Recall Event ID 98111
510(K)NumberK193215 K230972 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Code Information MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358; UDI-DI: 00884838088115; Serial Numbers: 45414, 45245, 45090, 45049, 45034, 45250, 45075, 45290, 45320, 45011, 45191, 45277, 45278, 45028, 45147. (2) Product Code (REF): 782107; UDI-DI: 00884838098336; Serial Numbers: 62031, 45533, 62051, 62182, 62024, 62047, 62048, 62052, 45519, 62181, 62081, 62153, 62088, 45589, 62073. (3) Product Code (REF): 782136; UDI-DI: 00884838108608; Serial Numbers: 28503.
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA Determined
Cause 2		Software design
ActionPhilips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620).
Quantity in Commerce31 units
DistributionWorldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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