The Recall Desk
HighFDA (Devices)·Z-2053-2021·Announced 2021-07-21

MRI Scanner Patient Orientation Button Confusion May Flip Diagnostic Images

GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.

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 a FDA Class II recall with no reported injuries or illnesses. However, it presents a risk-of-harm scenario where a user interface error could lead to incorrectly oriented diagnostic images, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling 311 SIGNA Architect whole-body magnetic resonance imaging (MRI) scanners that have been distributed worldwide. The recall addresses a user interface issue in the system's operation.

The 'Patient Orientation' button may be inadvertently clicked when a technician intends to click the 'Save RX' button. This button confusion can cause the system to change the prescribed patient orientation prior to running the initial 3-Plane Localizer Scan. When a patient orientation is selected and saved that does not match the patient's actual body position, the resulting diagnostic images may be incorrectly annotated or flipped.

The recalled product

Product
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • image-flipping
  • diagnostic-error

Distribution

Distribution scope not specified by the agency.

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