The Recall Desk
HighFDA (Devices)·Z-2058-2021·Announced 2021-07-21

MRI Imaging System UI Defect May Cause Incorrect Image Orientation

GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented 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 is an FDA Class II medical device recall with no reported injuries or illnesses. However, the software defect directly affects diagnostic imaging accuracy, presenting a risk of misdiagnosis if incorrect image orientations are not caught by operators. This falls under 'risk-of-harm products where injury has not yet been reported,' warranting a High severity.

Plain-English summary

GE Healthcare has recalled 1,737 SIGNA Creator and SIGNA Explorer Nuclear Magnetic Resonance Imaging Systems worldwide due to a software user interface defect.

The affected systems contain a button-clicking issue in which the 'Patient Orientation' button can be inadvertently activated when users intend to click the 'Save RX' button. When this occurs, the system's prescribed patient orientation setting is changed prior to running the initial 3-Plane Localizer Scan. This incorrect orientation setting may result in diagnostic images that are incorrectly annotated or flipped, which could affect the accuracy of radiological interpretation.

The recall affects all users of these systems worldwide.

The recalled product

Product
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
  • software-defect
  • image-orientation-error

Distribution

Distribution scope not specified by the agency.

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