GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect
GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves a potential cryogenic ventilation system defect. Per the severity rubric, risk-of-harm products without reported injury receive a High severity score.
Plain-English summary
GE Healthcare is recalling approximately 17,228 superconducting magnet systems used in SIGNA Creator and SIGNA Explorer magnetic resonance imaging (MRI) systems.
The recall is due to a potential defect in the cryogen ventilation system. The affected systems could have cryogen venting systems that do not meet required venting standards.
The devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands. They were also distributed internationally to numerous countries.
Users of affected systems should contact GE Healthcare for information regarding the recall.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- 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 · cryogenic ventilation defect
See all →- HighGE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect
FDA (Devices) · 2022-02-16