GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation
GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving a potentially defective cryogen ventilation system in medical imaging equipment. While no illnesses or injuries are currently reported, cryogenic system failures pose a significant risk of harm to facility personnel and patients, warranting a High severity score per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling GE Healthcare MR superconducting magnets, which are key components of the Discovery MR750 3.0T magnetic resonance imaging (MRI) system. A total of 17,228 devices are affected by this recall.
The superconducting magnets could have a cryogen ventilation system that does not meet venting requirements. Inadequate ventilation of cryogenic materials in these systems poses potential safety risks to personnel and patients in medical facilities.
The affected systems were distributed nationwide, including Puerto Rico and the Virgin Islands. Distribution also included U.S. government and military organizations. The devices were further distributed internationally across numerous countries.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T 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
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · cryogen ventilation defect
See all →- HighGE SIGNA MRI Systems Recalled for Cryogen Ventilation Defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Recalled for Cryogen Ventilation Issue
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MR superconducting magnets recalled due to cryogen ventilation system defect
FDA (Devices) · 2022-02-16
Similar recalls
- SevereGE Healthcare Recalls MSK 1.5T Extreme MR Scanners Due to Gas Venting Defect
FDA (Devices) · 2016-06-15
- HighGE Medical Systems Recalls Discovery MR750 3.0T Scanners for Shock Hazard
FDA (Devices) · 2017-08-23
- CriticalGE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
FDA (Devices) · 2015-02-25
- HighGE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk
FDA (Devices) · 2018-10-31
- HighGE Discovery MR750 MRI System May Produce Incomplete Diagnostic Images
FDA (Devices) · 2021-10-27
- SevereGE Healthcare Recalls Optima 1.5T MR430s MR Scanners Due to Gas Venting Defect
FDA (Devices) · 2016-06-15