GE Healthcare Recalls Signa HDxt 3.0T MRI Scanners for SAR Limit Concerns
GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.
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: The recall involves a risk-of-harm product (MRI scanner) where the hazard is a potential exceedance of safety limits (SAR) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 215 units of the Signa HDxt 3.0T whole body magnetic resonance scanner. The recall affects the 1.5T and 3.0T Signa HDx families used for diagnostic imaging. The devices were distributed worldwide, including nationwide in the United States and in numerous international markets.
The recall is issued because, during head or neck scans, the currently displayed Specific Absorption Rate (SAR) values could be lower than the actual SAR in the head. Modeling predicts that the actual head SAR could exceed the IEC60601-2-33 limit of 3.2 W/kg for some scans. This discrepancy means the safety limits displayed to operators may not accurately reflect the actual energy absorbed by the patient's head.
The recall is classified as Class II by the FDA. No specific instructions for end-users are provided in the source text, but the recall is directed at the medical device itself to address the potential safety limit exceedance.
The recalled product
- Product
- GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Scanner
- Affected units
- 215
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare 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 7 products in this recall →Related recalls
Same manufacturer · GE Healthcare
See all →- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
Same hazard · sar exceedance
See all →- HighGE Healthcare Recalls MRI Scanners Due to Potential SAR Limit Exceedance
FDA (Devices) · 2015-11-18
Similar recalls
- HighGE MRI Scanners Recalled for Potential Power Supply Shock Hazard
FDA (Devices) · 2017-08-23
- HighGE Signa MRI Systems Recalled for Potential Shock Hazard
FDA (Devices) · 2017-08-23
- HighGE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk
FDA (Devices) · 2013-08-21
- ModerateGE Healthcare Recalls MRI Systems Due to Reporting Tool Error
FDA (Devices) · 2013-03-20
- ModerateGE Healthcare Recalls MRI Scanners Due to Non-Unique Series Identifiers
FDA (Devices) · 2013-10-02
- HighGE SIGNA HDxt 3.0T MRI systems may overheat implanted devices
FDA (Devices) · 2024-08-14