Philips Medical Systems DMC GmbH
Hamburg, DE
Philips Medical Systems DMC GmbH appears in FDA device records in Hamburg, DE. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 45 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Philips Medical Systems DMC GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Philips Medical Systems GmbH, Dmc510(k), enforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Philips Medical Systems DMC GmbH between 2007 and 2024. The busiest year on record is 2017, with 3. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 3 |
| 2023 | 1 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233662 | Radiography 7300 C | KPR | Substantially Equivalent | |
| K233678 | Radiography 7000 M | IZL | Substantially Equivalent | |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | JAA | Substantially Equivalent | |
| K232910 | CombiDiagnost R90 | JAA | Substantially Equivalent | |
| K212186 | Philips Radiology Smart Assistant | KPR | Substantially Equivalent | |
| K212837 | ProxiDiagnost N90 | JAA | Substantially Equivalent | |
| K210692 | DigitalDiagnost | KPR | Substantially Equivalent | |
| K203087 | CombiDiagnost R90 | JAA | Substantially Equivalent | |
| K202564 | DigitalDiagnost C90 | MQB | Substantially Equivalent | |
| K182973 | DigitalDiagnost C90 | MQB | Substantially Equivalent | |
| K173433 | ProxiDiagnost N90 | OWB | Substantially Equivalent | |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | MQB | Substantially Equivalent | |
| K170113 | pixium 4343RCE | MQB | Substantially Equivalent | |
| K163210 | Philips CombiDiagnost R90 | JAA | Substantially Equivalent | |
| K153318 | Philips Eleva Workspot with SkyFlow | MQB | Substantially Equivalent | |
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST | MQB | Substantially Equivalent | |
| K140771 | PHILIPS ELEVA WORKSPOT | MQB | Substantially Equivalent | |
| K131483 | PHILIPS PIXIUM 4343RC | MQB | Substantially Equivalent | |
| K070528 | PHILIPS ESSENTA DR | MQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003768251 | 3003768251 | Philips Medical Systems DMC GmbH | Roentgenstrasse 24, HAMBURG 22335 DE | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- IXACassette, Radiographic Film
- KPWDevice, Beam Limiting, X-Ray, Diagnostic
- IXLDevice, Spot-Film
- MUEFull Field Digital, System, X-Ray, Mammographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXJGrid, Radiographic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- OWBInterventional Fluoroscopic X-Ray System
- IWEMonitor, Patient Position, Light-Beam
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IZZTable, Radiographic, Non-Tilting, Powered
- IXQTable, Radiographic, Stationary Top
- IXRTable, Radiographic, Tilting
- KXJTable, Radiologic
- IYBTube Mount, X-Ray, Diagnostic
Recall records
Showing 25 of 45| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0466-2026 | Radiography 7300 C; Model Number: 712037; | 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. | Class II | Open, Classified | |
| Z-0465-2026 | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; | 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. | Class II | Open, Classified | |
| Z-0464-2026 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; | 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. | Class II | Open, Classified | |
| Z-0463-2026 | Precision CRF; Model Number: 706400; | 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. | Class II | Open, Classified | |
| Z-0462-2026 | CombiDiagnost R90; Model Number: 709031; | 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. | Class II | Open, Classified | |
| Z-0461-2026 | ProxiDiagnost N90; Model Number: 706110; | 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. | Class II | Open, Classified | |
| Z-1326-2022 | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting. | Class II | Open, Classified | |
| Z-1329-2022 | DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting. | Class II | Open, Classified | |
| Z-1328-2022 | DigitalDiagnost C90 High Performance. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting. | Class II | Open, Classified | |
| Z-1327-2022 | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting. | Class II | Open, Classified | |
| Z-1325-2022 | ProxiDiagnost N90. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting. | Class II | Open, Classified | |
| Z-2357-2021 | CombiDiagnost R90 Software Version R1.0 and R1.1 | Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image. | Class II | Open, Classified | |
| Z-1329-2020 | CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production. | Class II | Terminated | |
| Z-1328-2020 | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production. | Class II | Terminated | |
| Z-0612-2019 | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System | kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. | Class II | Terminated | |
| Z-0239-2019 | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228. | Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline | Class II | Terminated | |
| Z-2868-2018 | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 | 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. | Class II | Terminated | |
| Z-2867-2018 | EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 | 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. | Class II | Terminated | |
| Z-2866-2018 | DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 | 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. | Class II | Terminated | |
| Z-2865-2018 | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 | 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. | Class II | Terminated | |
| Z-2864-2018 | DigitalDiagnost Upgrades (Stitching Patient Support) 712083 | 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. | Class II | Terminated | |
| Z-2863-2018 | DigitalDiagnost Single Detector (Stitching Patient Support) 712020 | 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. | Class II | Terminated | |
| Z-2862-2018 | 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. | Class II | Terminated | |
| Z-2861-2018 | 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. | Class II | Terminated | |
| Z-2860-2018 | DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain