MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Ingenia Elition X; Full-body MRI system, superconducting magnet

Model Number	Ingenia Elition X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Insufficient Information (4580)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury

• Brand Name: Ingenia Elition X
• Common Device Name: Full-body MRI system, superconducting magnet
• Manufacturer (Section D): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 50561666
• Report Number: 3042177665-2026-000146
• Device Sequence Number: 21321008
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: Ingenia Elition X
• Device Catalogue Number: 781358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown