GE SIGNA HDxt MRI System: Orientation Button Error Risk
GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.
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: This is an FDA Class II medical device recall affecting diagnostic imaging equipment. While the device creates a risk of diagnostic error through image misorientation, the source text reports no instances of actual injury, illness, or hospitalization. The recall addresses a theoretical harm situation without documented patient impact.
Plain-English summary
GE Healthcare is recalling 91 units of the 1.5T SIGNA HDxt (HD28) MR System, a nuclear magnetic resonance imaging system distributed worldwide.
The recall addresses a user interface issue where the Patient Orientation button on the system may be inadvertently clicked when the operator intends to click the Save RX button. This confusion can occur before the initial 3-Plane Localizer Scan is executed.
When the Patient Orientation button is selected and saved instead of the intended Save RX action, the prescribed patient orientation on the system becomes incorrect. This results in incorrectly annotated or flipped diagnostic images.
The recalled product
- Product
- 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 91
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.
See all 14 products in this recall →Related recalls
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