The Recall Desk
HighFDA (Devices)·Z-2054-2021·Announced 2021-07-21

GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue

GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or 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: FDA Class II recall affecting diagnostic imaging devices where a user interface design flaw could result in incorrect image orientation or annotation. The recall addresses a risk of harm through diagnostic error, though no patient harm has been reported.

Plain-English summary

GE Healthcare is recalling approximately 460 SIGNA Pioneer whole-body magnetic resonance (MRI) scanners used for high-resolution diagnostic imaging. The systems are distributed worldwide.

The control interface includes a "Patient Orientation" button positioned near a "Save RX" button. Due to this proximity, an operator may inadvertently click the Patient Orientation button when attempting to click Save RX. Selecting and saving an incorrect patient orientation—one that does not match the patient's actual position on the scanner—alters the system's configuration before the initial 3-Plane Localizer Scan, resulting in incorrectly annotated or flipped images.

Misoriented or incorrectly annotated images may compromise diagnostic accuracy and lead to misdiagnosis. This Class II recall was initiated by GE Healthcare, the manufacturer.

The recalled product

Product
SIGNA Pioneer - 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 / MRI
Hazard
  • ui-design-flaw
  • image-misorientation
  • diagnostic-error

Distribution

Distribution scope not specified by the agency.

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