Solid State X-ray Imager (flat Panel/digital Imager)
Radiology · 21 CFR 892.1680
Recent MDR events
1,277 adverse event reports on file
- MobileDiagnost wDR 2.2Jul 10, 2026InjuryPhilips Medical Systems Dmc Gmbh3003768251-2026-100016
- DIGITALDIAGNOST 4.1 HIGH PERFORMANCEJun 30, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100014
- DIGITALDIAGNOST 4.1 HIGH PERFORMANCEJun 5, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100010
- DIGITALDIAGNOST C90 HIGHPERFORMANCEApr 3, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100005
- DIGITALDIAGNOST 4.1 CHEST / EMERGENCYApr 1, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100004
- DIGITALDIAGNOST 4.1 HIGH PERFORMANCEMar 2, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100003
- CANON PORTABLE XRAY MACHINEFeb 10, 2026InjuryCanon Medical Systems CorporationMW5183632
- DIGITALDIAGNOST C90 FLEX/VALUE/CHEST/EMERGENCY ROOMFeb 2, 2026MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2026-100001
- DIGITALDIAGNOST 3.1.XJan 13, 2026InjuryPhilips Medical Systems Dmc Gmbh3003768251-2026-100000
- DIGITALDIAGNOST C90 HIGHPERFORMANCEDec 19, 2025MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2025-000162
Event type breakdown
Recalls
195 recall events for this product code
- Philips North America LlcOpen, ClassifiedJun 5, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Z-2354-2026 · View FDA record ↗ - Philips Medical Systems DMC GmbHOpen, ClassifiedNov 7, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER;
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-0465-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedJun 30, 2023
DigitalDiagnost C90, Model No. 712034 and 712035
There is a software login in issue that may prevent the user from logging in.
Z-2042-2023 · View FDA record ↗ - Swissray Medical AGTerminatedJan 8, 2019
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)
A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured.
Z-0697-2019 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2841-2018 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
DigitalDiagnost 4 Flex / Value
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2842-2018 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2843-2018 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2844-2018 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2845-2018 · View FDA record ↗ - Philips Medical Systems Gmbh, DMCTerminatedAug 17, 2018
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Z-2846-2018 · View FDA record ↗
Registered firms
687 firms currently registered for this product code
Iray Korea Limited
Seoul, KR
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
Rayence Co., Ltd.
Hwaseong-si Gyeonggi, KR
Block Imaging Parts & Service
Holt, MI, US
Careray Digital Medical Technology Co., Ltd.
SuZhou Jiangsu, CN
Radiology Information Systems, Inc.
DULLES, VA, US
Ge Healthcare (china) Co., Ltd.
Beijing, CN
Iray Group
Shanghai, CN
Ray America Inc
Fort Lee, NJ, US
H&abyz
Yongin-si Gyeonggi, KR
Medical Imaging Sale And Service Inc
Farmingdale, NJ, US
Agfa N.v.
Mortsel Antwerpen, BE
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Fujifilm Healthcare Manufacturing Corporation Hanamaki Office
HANAMAKI-SHI Iwate, JP
Anda Medical
Oshawa Ontario, CA
Dentsply Llc
York, PA, US
Medicatech Usa
Anaheim, CA, US
Drtech Corporation
Seongnam-si Gyeonggi, KR
Drgem Corporation
Gwangmyeong-si Gyeongbuk, KR
Canon Components, Inc.
KODAMA-GUN Saitama, JP
510(k) clearances
424 clearances for this product code
- Rayence Co., Ltd.Jul 31, 2026
K253800 · 0909FCE, 0909FCE-HS
- Vieworks Co., Ltd.Jun 18, 2026
K260820 · VIVIX-S 4386W (FXRD-4386WA)
- Konica Minolta Healthcare Americas, Inc.Jun 12, 2026
K252996 · Universal 1417PI
- Iray Imaging Technology (Haining) LimitedOct 9, 2025
K252911 · Lux HD 2530 detector (Lux HD 2530)
- Innocare Optoelectronics Corp.Jul 22, 2025
K250211 · Yushan X-Ray Flat Panel Detector
- Konica Minolta, Inc.Jun 17, 2025
K250665 · SKR 3000
- Allengers Medical Systems LimitedApr 18, 2025
K243734 · Wireless/ Wired X-Ray Flat Panel Detectors
- DRTECH CorporationMar 20, 2025
K242770 · EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG