System, Nuclear Magnetic Resonance Imaging
Radiology · 21 CFR 892.1000
Recent MDR events
4,713 adverse event reports on file
- uMR OmegaJul 31, 2026MalfunctionShanghai United Imaging Healthcare Co.,ltd.3011015597-2026-00001
- Discovery MR750wJul 29, 2026InjuryGe Medical Systems, Llc2183553-2026-00007
- OASIS MRI SystemJul 28, 2026InjuryFujifilm Corporation1000513161-2026-00020
- uMR OmegaJul 28, 2026MalfunctionUih Technologies, Llc3014809646-2026-00001
- IngeniaJul 27, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042177665-2026-000121
- IngeniaJul 27, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042177665-2026-000123
- IngeniaJul 27, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042177665-2026-000122
- MAGNETOM Symphony A TimJul 27, 2026InjurySiemens Healthineers Ag3002808157-2026-00018
- NAJul 27, 2026InjuryGe Medical Systems, Llc2183553-2026-00006
- SMARTPATH TO DSTREAM FOR 1.5TJul 22, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042177665-2026-000116
Event type breakdown
Recalls
699 recall events for this product code
- Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Achieva 1.5T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1951-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Achieva 1.5T Initial system with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1952-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Achieva 3.0T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1953-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Evolution Upgrade 1.5T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1954-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Evolution upgrade 3.0T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1955-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Ingenia 1.5T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1956-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Ingenia 1.5T CX with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1957-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Ingenia 3.0T with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1958-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Ingenia 3.0T CX with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1959-2026 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedApr 27, 2026
Philips Ingenia Ambition S with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1960-2026 · View FDA record ↗
Registered firms
1,041 firms currently registered for this product code
Ge Healthcare Coils
AURORA, OH, US
Ge Healthcare (tianjin) Company Limited
Tianjin, CN
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Block Imaging Parts & Service
Holt, MI, US
Siemens Shenzhen Magnetic Resonance Ltd.
SHENZHEN Guangdong, CN
Ge Medical Systems, Llc
WAUKESHA, WI, US
Ge Healthcare Manufacturing Llc
FLORENCE, SC, US
20med Pte Ltd
Singapore Central Singapore, SG
Nordicneurolab As
BERGEN Hordaland, NO
Canon Inc.
OHTA-KU Tokyo, JP
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Elekta Solutions Ab
STOCKHOLM, SE
Medical Resale Pty Limited
Caloundra QLD Queensland, AU
Siemens Healthineers Ag
ERLANGEN Bavaria, DE
Philips India Limited - Magnetic Resonance Business Unit
Bengaluru Karnataka, IN
Cnmc Co., Inc.
Nashville, TN, US
Medtec Llc
Orange City, IA, US
Canon Inc.
OTAWARA-SHI Tochigi, JP
Esaote North America, Inc
Fishers, IN, US
510(k) clearances
1,101 clearances for this product code
- Esaote, S.p.A.Jul 31, 2026
K261331 · I-Genius (100019400)
- Siemens Healthineers AGJul 31, 2026
K260852 · MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
- Shanghai United Imaging Healthcare Co., Ltd.May 22, 2026
K260113 · uMR Astra
- Fujifilm CorporationApr 6, 2026
K253862 · APERTO Lucent MRI System
- Esaote, S.p.A.Mar 27, 2026
K260746 · S-scan Open (100001800)
- Canon Medical Systems CorporationMar 27, 2026
K253625 · Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- Nordicneurolab ASMar 20, 2026
K251937 · nordicAudio (1.0)
- Aspect Imaging, Ltd.Mar 13, 2026
K254277 · Embrace Neonatal MRI System