Philips Medical Systems DMC GmbH FDA Record
- Latest inspection VAI · Jan 19, 2023
- No warning letters matched by name
Philips Medical Systems DMC GmbH has 11 FDA recalls, 3 inspections, 18 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Philips Medical Systems DMC GmbH" is on file.
- Latest recall
- Z-0300-2027 · Oct 6, 2026 · filed under Philips Medical Systems Nederland
- Latest recall under this name
- Z-0466-2026 · Class II · Oct 1, 2025
- Latest inspection
- Jan 19, 2023 · VAI
- Latest 510(k)
- Jun 13, 2024
Newer recall under related name Philips Medical Systems Nederland: Oct 6, 2026, Z-0300-2027.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 11 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 18 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Philips Medical Systems DMC GmbH: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 6 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 5 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0466-2026 | Class II | Radiography 7300 C; Model Number: 712037; | Oct 1, 2025 |
| Z-0462-2026 | Class II | CombiDiagnost R90; Model Number: 709031; | Oct 1, 2025 |
| Z-0464-2026 | Class II | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; | Oct 1, 2025 |
| Z-0463-2026 | Class II | Precision CRF; Model Number: 706400; | Oct 1, 2025 |
| Z-0461-2026 | Class II | ProxiDiagnost N90; Model Number: 706110; | Oct 1, 2025 |
| Z-0465-2026 | Class II | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2)… | Oct 1, 2025 |
| Z-1327-2022 | Class II | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system | May 19, 2021 |
| Z-1325-2022 | Class II | ProxiDiagnost N90. radiography and fluoroscopy system | May 19, 2021 |
| Z-1326-2022 | Class II | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | May 19, 2021 |
| Z-1328-2022 | Class II | DigitalDiagnost C90 High Performance. radiography and fluoroscopy system | May 19, 2021 |
| Z-1329-2022 | Class II | DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system | May 19, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 19, 2023 | Hamburg, Germany | Devices | Voluntary Action Indicated (VAI) | 3003768251 |
| Jul 9, 2015 | Hamburg, Germany | Devices | No Action Indicated (NAI) | 3003768251 |
| Jun 14, 2013 | Hamburg, Germany | Devices | No Action Indicated (NAI) | 3003768251 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003768251 | Hamburg, Germany | 3 | Jan 19, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K233662 | Radiography 7300 C | Jun 13, 2024 |
| K233678 | Radiography 7000 M | Feb 14, 2024 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Jan 11, 2024 |
| K232910 | CombiDiagnost R90 | Oct 19, 2023 |
| K212186 | Philips Radiology Smart Assistant | Dec 13, 2021 |
| K212837 | ProxiDiagnost N90 | Sep 21, 2021 |
| K210692 | DigitalDiagnost | Apr 2, 2021 |
| K203087 | CombiDiagnost R90 | Dec 3, 2020 |
| K202564 | DigitalDiagnost C90 | Sep 30, 2020 |
| K182973 | DigitalDiagnost C90 | Jan 11, 2019 |
| K173433 | ProxiDiagnost N90 | Feb 5, 2018 |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Jul 7, 2017 |
| K170113 | pixium 4343RCE | Feb 9, 2017 |
| K163210 | Philips CombiDiagnost R90 | Jan 31, 2017 |
| K153318 | Philips Eleva Workspot with SkyFlow | Dec 22, 2015 |
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST | Jul 25, 2014 |
| K140771 | PHILIPS ELEVA WORKSPOT | Apr 25, 2014 |
| K131483 | PHILIPS PIXIUM 4343RC | Oct 7, 2013 |
Philips Medical Systems DMC GmbH and the FDA: common questions
Has Philips Medical Systems DMC GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Philips Medical Systems DMC GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Philips Medical Systems DMC GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Philips Medical Systems DMC GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Philips Medical Systems DMC GmbH?
The most recent FDA inspection on file ended Jan 19, 2023 at Hamburg, Germany and was classified VAI. FDA has 3 inspections of Philips Medical Systems DMC GmbH on file.
Has Philips Medical Systems DMC GmbH had an FDA recall?
Yes. Philips Medical Systems DMC GmbH has 11 FDA recalls on record. The most recent under this name started Oct 1, 2025. A newer recall, dated Oct 6, 2026, is filed under the related name Philips Medical Systems Nederland.
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