GE Healthcare Optima MR430s MRI systems have potential cryogenic ventilation defect
GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.
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 a Class II FDA medical device recall with an identified cryogenic ventilation system defect. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).
Plain-English summary
GE Healthcare is recalling certain Optima MR430s superconducting magnet systems, which are components of nuclear magnetic resonance (MRI) imaging systems used in medical facilities. A total of 17,228 devices are included in this field action.
The magnetic resonance systems could potentially have a cryogenic ventilation system that does not meet the venting requirements.
The affected devices were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. The systems also have extensive international distribution across numerous countries.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s 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 hazard
See all →- HighGE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare SIGNA MR Systems cryogenic ventilation system defect recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI systems recalled for cryogen ventilation defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI magnets recalled for cryogen ventilation defect
FDA (Devices) · 2022-02-16