GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths mentioned in the source text. The hazard is described as theoretical (systems "could potentially" have the defect) rather than confirmed harm. Per the severity rubric, recalls with no reported harm and theoretical hazards are rated as Moderate or lower.
Plain-English summary
GE Healthcare, LLC is recalling GE Healthcare MR superconducting magnets, a component of the GE Healthcare Orthone (1.0T MSK Extreme) System, a nuclear magnetic resonance imaging system. Approximately 17,228 devices are included in this field correction.
The superconducting magnets could potentially have a cryogen ventilation system that does not meet the required venting specifications. This defect could affect the proper functioning of the cryogen ventilation system.
The affected systems were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution was made to numerous countries worldwide.
Facilities with affected systems should contact GE Healthcare for instructions on inspection, remediation, or replacement of the affected magnets.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI System
- 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 system defect
See all →- HighGE Healthcare MR system magnets recalled due to cryogen ventilation defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare MR Magnets Cryogenic Ventilation System Defect Recall
FDA (Devices) · 2022-02-16