GE Healthcare Recalls Signa HD 3.0T MRI Systems Due to SAR Display Error
GE Healthcare is recalling 97 Signa HD 3.0T MRI systems because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.
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: The recall involves a risk-of-harm product (MRI system) where the safety limit for Specific Absorption Rate (SAR) may be exceeded, but no injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 97 units of the Signa HD 3.0T MRI system, an open, whole-body diagnostic imaging device. The recall covers units distributed worldwide, including the United States and numerous international locations.
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. SAR modeling predicts that the actual SAR in the head 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 energy absorbed by the patient's head.
The affected units are identified by specific serial numbers listed in the recall documentation. Healthcare facilities using these devices should contact GE Healthcare for instructions on how to resolve the issue and ensure patient safety during imaging procedures.
The recalled product
- Product
- GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room displa
- Manufacturer
- GE Healthcare
- Affected units
- 97
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 radiology viewer may show patient information not matching displayed images
FDA (Devices) · 2026-03-11
- HighGE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access
FDA (Devices) · 2025-04-09
- HighGE Healthcare Cardiology CA1000 Security Vulnerability Could Allow Patient Data Access
FDA (Devices) · 2025-04-09
- HighGE Healthcare Centricity Radiology RA600 and related imaging systems login vulnerability
FDA (Devices) · 2025-04-09
- HighGE Healthcare Medical Imaging Software Vulnerability Allows Unauthorized System Access
FDA (Devices) · 2025-04-09
Same hazard · sar exposure
See all →- HighGE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning
FDA (Devices) · 2024-08-14
- HighCanon MRI Systems Recall Due to SAR Display Error
FDA (Devices) · 2018-10-31
- HighGE Healthcare Recalls SIGNA PET/MR 3.0T Scanners for SAR Display Error
FDA (Devices) · 2015-11-18
- HighGE Healthcare Recalls SIGNA Excite 3.0T MR Systems for SAR Display Error
FDA (Devices) · 2015-11-18
- HighGE Healthcare Recalls Signa HDx 3.0T MRI Scanners for SAR Display Error
FDA (Devices) · 2015-11-18