The Recall Desk
HighFDA (Devices)·Z-2057-2021·Announced 2021-07-21

GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors

GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated 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: FDA Class II recall with no reported illnesses or injuries. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric criterion for Score 3. Incorrectly oriented medical images in a diagnostic imaging device present meaningful risk of diagnostic error.

Plain-English summary

GE Healthcare, LLC is recalling 71 SIGNA PET/MR medical imaging devices that have been distributed worldwide. The SIGNA PET/MR is a tomographic imager that combines emission computed tomography with nuclear magnetic resonance imaging.

GE Healthcare identified an issue where the "Patient Orientation" button may be inadvertently clicked when the user intends to click the "Save RX" button. If the incorrect button is selected, it changes the patient orientation setting on the system prior to running the initial 3-Plane Localizer Scan.

Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

The recalled product

Product
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
  • interface-error
  • image-orientation-error
  • mis-annotation

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category