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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 71
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 14 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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