System, Nuclear Magnetic Resonance Spectroscopic
Radiology · 21 CFR 892.1000
Recent MDR events
15 adverse event reports on file
- MRI MACHINEMar 17, 2026MalfunctionUnkMW5185293
- SIEMENS ESPREE MRI SCANNER 1.5TJun 26, 2025InjurySiemens Healthineers AgMW5172038
- ECHELON MRI SYSTEMJun 20, 2024InjuryFujifilm Healthcare CorporationMW5156476
- SIEMENS SOFTWARE VERSION XA 30May 18, 2023InjurySiemens Ag/ Siemens Healthcare GmbhMW5117710
- ECHELON XL 1.5T MRI SYSTEMApr 28, 2022MalfunctionFujifilm Healthcare Corporation3018423337-2022-00004
- ECHELON XL 1.5T MRI SYSTEMApr 26, 2022MalfunctionFujifilm Healthcare Corporation1528028-2022-00022
- OASIS HIGH-FIELD BORE-LESS MRJan 7, 2015Hitachi Medical Systems America, Inc.4416409
- CONCERTO CRT-D DR ATOct 15, 2012InjuryMedtronic S.a.6000094-2012-02117
- TRIMA ACCEL ENHANCED PLT, PLS, RBC SETJun 15, 2012MalfunctionTerumo Bct1722028-2012-00364
- TRIMA ACCELL ENHANCED PLT, PLS, RBC SETMay 3, 2012MalfunctionCaridianbct1722028-2012-00271
Event type breakdown
Recalls
17 recall events for this product code
- Philips North AmericaOpen, ClassifiedFeb 1, 2024
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0945-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0946-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0947-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0948-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Achieva XR. Model (REF) Numbers 781153, 781253.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0949-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0950-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0951-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0952-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0953-2024 · View FDA record ↗ - Philips North AmericaOpen, ClassifiedFeb 1, 2024
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Z-0954-2024 · View FDA record ↗
Registered firms
297 firms currently registered for this product code
Ge Healthcare Coils
AURORA, OH, US
Siemens Shenzhen Magnetic Resonance Ltd.
SHENZHEN Guangdong, CN
Ge Healthcare (tianjin) Company Limited
Tianjin, CN
Ge Healthcare Manufacturing Llc
FLORENCE, SC, US
20med Pte Ltd
Singapore Central Singapore, SG
Siemens Healthineers Ag
ERLANGEN Bavaria, DE
Philips India Limited - Magnetic Resonance Business Unit
Bengaluru Karnataka, IN
Lbn Medical A/s
Aalborg Nordjylland, DK
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Ge Healthcare (china) Co., Ltd.
Beijing, CN
510(k) clearances
10 clearances for this product code
- Hitachi Medical Systems America, Inc.Mar 16, 2010
K093044 · OASIS MRI SYSTEM
- Hitachi Medical Systems America, Inc.Jun 28, 2007
K071506 · ECHELON SPECTROSCOPY PACKAGE
- Ge Medical Systems, Inc.Aug 22, 2001
K011604 · PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
- Toshiba America Medical Systems, In.CApr 5, 2001
K010129 · EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
- GE Medical SystemsJan 17, 2001
K003575 · MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
- Philips Medical Systems (Cleveland), Inc.Jul 19, 1999
K991568 · MR SPECTROSCOPY PACKAGE
- GE Medical SystemsJan 12, 1999
K984167 · SAGE 7
- Siemens Medical Solutions USA, Inc.Apr 3, 1997
K962627 · CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM