GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.
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 of medical imaging equipment with a potential safety defect in the cryogenic ventilation system. No injuries or illnesses reported; this constitutes a risk-of-harm situation per the severity rubric.
Plain-English summary
GE Healthcare is recalling 17,228 superconducting magnets that are components of GE SIGNA 1.5T TwinSpeed magnetic resonance imaging systems. The affected systems have a cryogen ventilation system that does not meet required venting specifications.
The recall affects systems distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as government and military installations. International distribution spans more than 100 countries and territories.
No injuries or illnesses have been reported.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 17,228
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems.
Distribution
Part of a larger recall action
This product is one of 32 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 32 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · ventilation defect
See all →- SevereGE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall
FDA (Devices) · 2025-05-07
- HighGE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
FDA (Devices) · 2022-02-16