GE Healthcare Recalls AIR Technology Anterior Array MRI Coils
GE Healthcare is recalling 22 AIR Technology Anterior Array MRI coils because the outer seam may separate, exposing porous internal material that cannot be disinfected.
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: The recall involves a risk-of-harm product (infection risk from non-disinfectable material) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 22 units of the AIR Technology Anterior Array, a receive-only RF coil designed for use with GE 3.0T MRI systems. The affected catalogue numbers are 5746694, 5746695, and 5746696.
The recall is due to a defect where the outer seam of the coil, closest to the system cable, may separate. This separation can expose the porous material internal to the coil. Because this internal porous material cannot be disinfected, there is a risk of user and/or patient contact with infectious agents.
The affected units were distributed worldwide, including in the United States (AZ, CA, MS, NY, WI, DE) and in France, Germany, Japan, the Netherlands, Spain, and Sweden. Users should stop using the affected coils and contact GE Healthcare for instructions on return or replacement.
The recalled product
- Product
- AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Coil
- Hazard
- Affected units
- 22
Distribution
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 · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighGE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk
FDA (Devices) · 2018-10-31
- HighGE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk
FDA (Devices) · 2018-10-31
- ModerateGE Healthcare Recalls MR Scanners Due to Exposed Foam on End Bells
FDA (Devices) · 2013-10-09
- HighGE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error
FDA (Devices) · 2015-11-18
- SevereGE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk
FDA (Devices) · 2020-10-28
- HighGE Medical Systems Recalls Discovery MR750 3.0T Scanners for Shock Hazard
FDA (Devices) · 2017-08-23