Image-intensified Fluoroscopic X-ray System, Mobile
Radiology · 21 CFR 892.1650
Fluoroscopy of the human body.
Recent MDR events
10,986 adverse event reports on file
- O-Arm Imaging SystemJul 28, 2026InjuryMedtronic Navigation, Inc. (boxborough)3004785967-2026-00421
- O-Arm Imaging SystemJul 28, 2026MalfunctionMedtronic Navigation, Inc. (boxborough)3004785967-2026-00422
- ARCADIS Varic Gen2Jul 28, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00126
- O-Arm Imaging SystemJul 27, 2026MalfunctionMedtronic Navigation, Inc. (boxborough)3004785967-2026-00419
- O-ARM IMAGING SYSTEMJul 21, 2026MalfunctionMedtronic Navigation, Inc. (boxborough)3004785967-2026-00416
- O-ARM IMAGING SYSTEMJul 9, 2026MalfunctionMedtronic Navigation, Inc. (boxborough)3004785967-2026-00397
- O-ARM IMAGING SYSTEMJul 2, 2026MalfunctionMedtronic Navigation, Inc. (boxborough)3004785967-2026-00388
- O-ARM IMAGING SYSTEMJul 2, 2026InjuryMedtronic Navigation, Inc. (boxborough)3004785967-2026-00389
- ARCADIS AVANTIC GEN2Jun 23, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00113
- ARCADIS ORBIC GEN2Jun 9, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00097
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Device Operates Differently Than Expected”
No history to chart.
Recalls
49 recall events for this product code
- GE Medical Systems, LLCOpen, ClassifiedJun 9, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and cont
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Z-1819-2025 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedJun 9, 2025
OEC 3D
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Z-1820-2025 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedDec 18, 2024
OEC 3D REF
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Z-0703-2025 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedDec 18, 2024
OEC Elite REF
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Z-0704-2025 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedDec 18, 2024
OEC 9900 REF
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Z-0705-2025 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedDec 18, 2024
OEC 9800 REF
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Z-0706-2025 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedJul 31, 2023
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Z-2275-2023 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedJul 31, 2023
OEC 9900 Systems with 9-inch Image Intensifier
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Z-2277-2023 · View FDA record ↗ - GE OEC Medical Systems, IncOpen, ClassifiedJul 31, 2023
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER,
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Z-2279-2023 · View FDA record ↗ - GE OEC Medical Systems, IncTerminatedFeb 27, 2017
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Z-1469-2017 · View FDA record ↗
Registered firms
269 firms currently registered for this product code
Metropolis International, Llc
Long Island City, NY, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Philips India Limited
Pune Maharashtra, IN
Siemens Healthineers Ag
KEMNATH Bavaria, DE
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Block Imaging Parts & Service
Holt, MI, US
Medical Imaging Sale And Service Inc
Farmingdale, NJ, US
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Genoray Co., Ltd.
Seongnam-si Gyeonggi, KR
Philips Electronics Ltd
Mississauga Ontario, CA
A.t.s. Applicazione Tecnologie Speciali S.r.l.
Torre de Roveri Bergamo, IT
Lbn Medical A/s
Aalborg Nordjylland, DK
Ge Oec Medical Systems, Inc
SALT LAKE CITY, UT, US
Oxos Medical, Inc
Atlanta, GA, US
Skanray Technologies Limited
Mysore Karnataka, IN
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
510(k) clearances
82 clearances for this product code
- Allengers Medical Systems LimitedJun 5, 2026
K253296 · Digital C-ARM with 3D
- Ziehm-Orthoscan, Inc.Jan 14, 2026
K252579 · Orthoscan TAU MVP Mini C-Arm System
- Ge Hualun Medical Systems Co. , Ltd.Nov 26, 2025
K253269 · OEC One CFD
- Hefei Chimed Intelligent Machine Co., Ltd.Nov 6, 2025
K251004 · Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
- Ziehm-Orthoscan, Inc.Jul 2, 2025
K250587 · Orthoscan TAU Mini C-Arm
- Ziehm-Orthoscan, Inc.Jan 14, 2025
K243452 · Orthoscan VERSA Mini C-Arm
- Ge Hualun Medical Systems Co. , Ltd.Dec 27, 2024
K240828 · OEC One ASD
- Ge Oec Medical Systems, Inc.Mar 28, 2024
K233669 · OEC 3D