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

Model Number	SmartPath to dStream for 1.5T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction

• Brand Name: Ingenia
• 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: 50291935
• Report Number: 3042177665-2026-000131
• Device Sequence Number: 16132626
• Product Code: LNH
• UDI-Device Identifier: 00884838095076
• UDI-Public: (01)00884838095076
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SmartPath to dStream for 1.5T
• Device Catalogue Number: 781260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/18/2026
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2023-PD-MR-013
• Patient Sequence Number: 1
• Patient Sex: Unknown