Coil, Magnetic Resonance, Specialty
Radiology · 21 CFR 892.1000
Recent MDR events
134 adverse event reports on file
- SENTINELLEMay 8, 2026InjuryPhilips Medical Systems Nederland B.v.1056069-2026-000002
- PHILIPSApr 30, 2026InjuryPhilips Medical Systems Nederland B.v.1056069-2026-000001
- BREAST BI 7 MR COIL SET 3TApr 23, 2026InjuryNoras Mri Products Gmbh3004929307-2026-00001
- BREAST BI 7 MR COIL SET 3TApr 23, 2026InjuryNoras Mri Products Gmbh3004929307-2026-00002
- BREAST BI 7 MR COIL SET 3TApr 23, 2026InjuryNoras Mri Products Gmbh3004929307-2026-00003
- TXRX EXTREMITY INVIVO FOOT/ANKLE COILMar 26, 2026InjuryQuality ElectrodynamicsMW5185981
- SENSE XL TORSO COIL, 3.0TApr 7, 2025MalfunctionPhilips Medical Systems Nederland B.v.1056069-2025-000001
- SENSE XL TORSO COIL, 1.5T MK2Apr 2, 2025InjuryPhilips Electronics Nederland B.v.1051786-2025-000005
- INVIVODec 9, 2024InjuryPhilips Medical Systems Nederland B.v.3003768277-2024-007125
- SENSE XL TORSO COIL, 1.5T MK2Dec 5, 2024MalfunctionPhilips Medical Systems Nederland B.v.1056069-2024-000005
Event type breakdown
Recalls
38 recall events for this product code
- Philips North America LlcOpen, ClassifiedNov 25, 2024
Achieva TX Interventional Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0536-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0537-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
dS Breast 16ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0538-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
dS Breast 7ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0539-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
dS Breast 7ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0540-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
Mammotrak Diagnostic Coil 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0541-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
Mammotrak Interventional Coil 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0542-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
Mammotrak Diagnostic Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0543-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
Mammotrak Interventional Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0544-2025 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedNov 25, 2024
SENSE Breast Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0545-2025 · View FDA record ↗
Registered firms
794 firms currently registered for this product code
Ge Healthcare Coils
AURORA, OH, US
Philips Global Business Services Llp
Pune Maharashtra, IN
Ge Healthcare (tianjin) Company Limited
Tianjin, CN
Siemens Shenzhen Magnetic Resonance Ltd.
SHENZHEN Guangdong, CN
Quality Electrodynamics
Mayfield Village, OH, US
Lmt Medical Systems Gmbh
Lubeck Schleswig-Holstein, DE
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Dxtx Medical Inc.
Pittsburgh, PA, US
Inkspace Imaging, Inc
Pleasanton, CA, US
20med Pte Ltd
Singapore Central Singapore, SG
Medspira Llc
Minneapolis, MN, US
Siemens Healthineers Ag
ERLANGEN Bavaria, DE
510(k) clearances
490 clearances for this product code
- Philips Medical Systems Nederland B.V.Jul 30, 2026
K262330 · dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- Philips Medical Systems Nederland B.V.Jul 24, 2026
K262294 · dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T
- Neocoil, LLCApr 23, 2026
K260947 · 0.55T 12Ch Breast Coil
- Shenzhen RF Tech Co., Ltd.Apr 14, 2026
K252587 · HD 8Ch Wrist Array
- Shenzhen RF Tech Co., Ltd.Apr 1, 2026
K252876 · GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only
- Philips Healthcare (Suzhou) Co., Ltd.Mar 20, 2026
K260519 · Smart Fit TorsoCardiac 1.5T
- Shenzhen RF Tech Co., Ltd.Feb 10, 2026
K252179 · GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
- Ge Healthcare Coils (Usa Instruments, Inc.)Jan 23, 2026
K253738 · 3.0T AIR 32CH HNA