System, X-ray, Tomographic
Radiology · 21 CFR 892.1740
Recent MDR events
44 adverse event reports on file
- X-RAY MACHINEMay 26, 2021MalfunctionMW5101585
- DR 800 SYSTEM, X-RAY, TOMOGRAPHICDec 11, 2019MalfunctionAgfa N.v.3001556265-2019-00013
- DISCOVERY XR656Jun 26, 2015InjuryGe Hangwei Medical Systems Co., Ltd.9613445-2015-00005
- PHILIPS INTEGRIS HDec 30, 2014MalfunctionPhilipsMW5039954
- DEFINIUM 8000Mar 1, 2013OtherGe Medical System, Llc2126677-2013-00006
- GESep 17, 2012MalfunctionGe Healthcare2753159
- CLINIXE SYSTEMAug 1, 2012Philips Medical Systems (cleveland), Inc.1525965-2012-00044
- DEFINIUM 8000Jan 18, 2012MalfunctionGe Medical Systems, Llc2126677-2012-00007
- CESAR-OMCP-VISUB (HM3000)Aug 16, 2011MalfunctionPhilips Healthcare3003768277-2011-00503
- PLY C-OMCP-VISUB (H3000)Aug 4, 2011DeathPhilips Healthcare3003768277-2011-00447
Event type breakdown
Recalls
6 recall events for this product code
- AGFA Healthcare Corp.Open, ClassifiedDec 22, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Z-0923-2026 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
Poly C- DMCP-Visub(H3000), System Code 72238
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3237-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
Cesar-DMCP-Visub(HM2000/3000), System Code 72239
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3238-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
Cesar Powerpack-Visub(V3000), System Code 72243
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3239-2018 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJul 10, 2003
3D Ceiling Suspension
the back up safety catch may not function properly
Z-0987-03 · View FDA record ↗ - Agfa N.V.TerminatedUnknown
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic sl
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Z-1502-2020 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Block Imaging Parts & Service
Holt, MI, US
Adaptix Limited
Oxford Oxfordshire, GB
Kuehne Gmbh
Dortmund North Rhine-Westphalia, DE
Fujifilm Corporation
ASHIGARAKAMI-GUN Kanagawa, JP
Accogent Pausch
Tinton Falls, NJ, US
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Block Imaging Sas
Weyersheim Bas-Rhin, FR
Agfa N.v.
Mortsel Antwerpen, BE
Ge Healthcare (china) Co., Ltd.
Beijing, CN
General Medical Merate S.p.a.
SERIATE, BERGAMO, IT
Fair Medical Co.,ltd
Kashiwa Chiba, JP
Dagesh F.k. Ltd.
Yad Binyamin Central, IL
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Everx Pty Ltd
Sydney New South Wales, AU
Nano-x Imaging Ltd
PETAH TIKVA Central, IL
Fujifilm Healthcare Manufacturing Corporation Hanamaki Office
HANAMAKI-SHI Iwate, JP
Ge Medical Systems Monterrey Mexico, S.a. De C.v.
APODACA Nuevo Leon, MX
Agfa-gevaert Healthcare Gmbh
PEISSENBERG Bavaria, DE
510(k) clearances
42 clearances for this product code
- Nano-X Imaging , Ltd.Feb 2, 2026
K252649 · TAP2D
- Adaptix LimitedNov 6, 2025
K252133 · Adaptix Ortho350
- Nano-X Imaging , Ltd.Apr 16, 2025
K250850 · Nanox.ARC X
- Nano-X Imaging , Ltd.Dec 4, 2024
K242395 · Nanox.ARC
- Nano-X Imaging , Ltd.Apr 28, 2023
K222934 · Nanox.ARC
- Pausch Medical GmbHJan 26, 2023
K221949 · Ortho Device, ADAPTIX 3D Orthopedic Imaging System
- General Medical Merate S.P.AOct 26, 2021
K213081 · CLISIS SYSTEMS, Discovery RF180
- Agfa N.V.Mar 9, 2020
K193262 · DR 600 with Tomosynthesis