OMEGA UMR SCANNER 3T
Received Jul 1, 2026 · Event occurred Feb 6, 2026
Report MW5190139 · MDR key 25678161
Device
Generic name
System, Nuclear Magnetic Resonance Imaging
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.Product problems
- Image Orientation Incorrect
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTER STATES THAT THEY ARE A NEUROSURGEON AND ATTORNEY. STATED THAT BRAIN IMAGES TAKEN FOR TEN OF THEIR PATIENTS OFFICE ARE COMING OUT DISTORTED. THESE IMAGES WERE CAPTURED BY (B)(6). STATED THAT TEN PATIENTS HAVE HAD DISTORTED IMAGING WHICH INCLUDED PARTS OF THE BRAIN BEING MISSING FROM IMAGE OR LOCATED OUTSIDE OF THE SKULL IN THE IMAGE. NOTICED THAT A SIMILAR FINDING IN THE AMERICAN JOURNAL OF NEURO RADIOLOGY STATING THAT THE MANUFACTURER IS ACCELERATING 70% OF DATA WITH AI SOURCED MECHANISMS AND IMAGES. LEAVING OUT COMPLETE PARTS OF THE BRAIN IN THE IMAGES WHICH CAN CAUSE PARTS OF THE BRAIN TO BE HARMED DURING THE PROCEDURE. REPORTER SAID THAT THEY HAVE REPORTED THE DEVICE TO THE MANUFACTURER. REFERENCE REPORTS: MW5190135, MW5190136, MW5190137, MW5190138, MW5190140, MW5190141, MW5190142, MW5190143, MW5190144. PT: 4582. DEVICE: 1305. THIS REPORT CAPTURES: OMEGA UMR SCANNER 3T.