The Recall Desk
HighFDA (Devices)·Z-2063-2021·Announced 2021-07-21

MRI System Patient Orientation Button Click Error May Flip Images

GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a diagnostic imaging system with potential to produce incorrectly oriented images, which could affect diagnostic accuracy. No injuries, illnesses, or hospitalizations have been reported, placing this as a high-risk medical device issue without documented harm.

Plain-English summary

GE Healthcare is recalling 1,519 Optima MR450w 1.5T Nuclear Magnetic Resonance Imaging Systems distributed worldwide due to an interface issue that may result in diagnostic imaging errors.

The 'Patient Orientation' button on the system may be inadvertently clicked when attempting to click the 'Save RX' button. When patient orientation is unintentionally changed and saved, the system may use an incorrect patient position during initial 3-Plane Localizer Scans, resulting in images that are incorrectly annotated and/or flipped.

Healthcare facilities using these systems should take precautions to prevent accidental button clicks and verify that the correct patient orientation is selected and saved before each scan. Flipped or incorrectly oriented diagnostic images could compromise diagnostic accuracy and clinical decision-making.

Affected healthcare facilities should contact GE Healthcare for guidance on preventing unintended patient orientation changes and should report any instances where this issue may have affected diagnostic imaging.

The recalled product

Product
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / MRI Systems
Hazard
  • image-orientation-error
  • ui-button-confusion

Distribution

Distribution scope not specified by the agency.

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