OASIS MRI SYSTEM
Received Jun 26, 2026 · Event occurred May 11, 2026
Report 1000513161-2026-00012 · MDR key 25640975
Device
Generic name
System, Nuclear Magnetic Resonance Imaging
Manufacturer
Fujifilm CorporationModel number
SYS/MR/OASIS OPEN+VERTEX IIProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Discomfort
Narrative
Description of Event or Problem
ON 05/29/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. THE CUSTOMER REPORTED THAT A PATIENT COMPLAINED OF PAIN IN THEIR LEFT HANDS WHEN MOVED INTO THE GANTRY. THE PATIENT #1 DID NOT SEEK ANY FURTHER MEDICAL ATTENTION BUT DID NOT COMPLETE THE STUDY THAT THEY WERE ORIGINALLY SCHEDULED. FUJI ENGINEER HAS COMPLETED THE TRANSMITTER TESTING AND TEMPERATURE TESTING. DUE TO THE UNCONFIRMED FOLLOW UP TO COMPLETE THE ORIGINALLY SCHEDULED STUDY, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. RELATED: PATIENT 2 - 1000513161-2026-00013. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).