OASIS MRI System
Received Jul 28, 2026 · Event occurred Jul 15, 2026
Report 1000513161-2026-00020 · MDR key 50063734
Device
Generic name
System, Nuclear Magnetic Resonance Imaging
Manufacturer
Fujifilm CorporationProduct problems
- Excessive Heating
Patient
62 YR · Female
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
On (b)(6) 2026, FUJIFILM Healthcare Americas Corporation became aware of an event involving SYS/MR/OASIS OPEN+VERTEX II. The patient was scanned on (b)(6) 2026 with the XLG flex coil. The patient did not have any issues or mention any burning on the date of the exam.The patient went to a dermatologist and was diagnosed to have a 2nd degree burn on their right arm. The patient reported their 2nd degree burn diagnosis to the facility on (b)(6) 2026.FUJIFILM Healthcare Americas Corporation is reporting this event, due to the 2nd degree burn to the right arm of the patient.Ref:FUJIFILM Healthcare Americas Corporation Complaint # (b)(4).