IMRIS IMRI 3T V
Received Mar 19, 2026 · Event occurred Feb 25, 2026
Report 3010326005-2026-00003 · MDR key 24639926
Device
Generic name
System, Nuclear Magnetic Resonance Imaging
Manufacturer
Imris Imaging, IncModel number
120823-000Product problems
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE MAGNET MOVER EXPERIENCED A MECHANICAL MALFUNCTION CAUSING AN UNEXPECTED DOWNTIME CONDITION WITH A PATIENT UNDER ANESTHESIA FOR MORE THAN ONE HOUR, LEADING TO AN EXTENDED PROCEDURAL DELAY. PER THE SITE, THE PATIENT REMAINED STABLE, AND NO ADVERSE EVENTS OR UNANTICIPATED PATIENT OUTCOMES WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE.
Additional Manufacturer Narrative
THIS EVENT WAS REPORTED DUE TO THE LENGTH OF PROCEDURAL DELAY UNDER ANESTHESIA REPORTED BY THE END USER. THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT. THE MANUFACTURER HAS INITIATED INTERNAL CORRECTIVE ACTION TO FURTHER ADDRESS THIS ISSUE.