The Recall Desk
HighFDA (Devices)·Z-2062-2021·Announced 2021-07-21

MRI System User Interface Error May Cause Incorrectly Flipped Images

GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.

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 recall involving a medical imaging device where a user interface defect could result in misoriented diagnostic images and potential diagnostic error. No illnesses or injuries have been reported, but the risk-of-harm nature of medical imaging systems combined with the potential for image misinterpretation meets the criteria for High severity.

Plain-English summary

GE Healthcare SIGNA Voyager Nuclear Magnetic Resonance Imaging Systems are subject to this recall due to a user interface defect where the "Patient Orientation" button may be inadvertently clicked when intending to click the "Save RX" button. This accidental button press may cause the system to save an incorrect patient orientation prior to running the initial 3-Plane Localizer Scan.

When an incorrect patient orientation is saved, the resulting MRI images may be incorrectly annotated or flipped. This image orientation error could affect the accuracy of medical image interpretation by clinicians.

Approximately 541 SIGNA Voyager devices are affected by this issue and have been distributed worldwide. Operators of affected systems should be aware of this user interface defect and may contact GE Healthcare for guidance on managing this issue.

The recalled product

Product
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / MRI System
Hazard
  • user-interface-error
  • image-flipping
  • incorrect-annotation

Distribution

Distribution scope not specified by the agency.

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