Chrysalis Intelligence · Sponsors · Philips Medical Systems Dmc GmbH

Philips Medical Systems Dmc GmbH

Hamburg, DE · 9 510(k) clearances · 11 recalls

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Total clearances
9
2020-09-30 → 2024-06-13
Last 12 months
0
Product codes
4
Most recent
2024-06-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
JAA System, X-Ray, Fluoroscopic, Image-Intensified Class II Radiology 4 2024-01-11
KPR System, X-Ray, Stationary Class II Radiology 3 2024-06-13
IZL System, X-Ray, Mobile Class II Radiology 1 2024-02-14
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II Radiology 1 2020-09-30
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
11
Most recent
2025-10-01
DateSeverityStatusRecall # ProductCodeReason
2025-10-01 Class II Ongoing 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…
2025-10-01 Class II Ongoing 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…
2025-10-01 Class II Ongoing 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…
2025-10-01 Class II Ongoing 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…
2025-10-01 Class II Ongoing 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…
2025-10-01 Class II Ongoing 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…
2021-05-19 Class II Ongoing 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…
2021-05-19 Class II Ongoing 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…
2021-05-19 Class II Ongoing 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…
2021-05-19 Class II Ongoing 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…
2021-05-19 Class II Ongoing 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…
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2024-06-13 K233662 Radiography 7300 C KPR Class II Radiology
2024-02-14 K233678 Radiography 7000 M IZL Class II Radiology
2024-01-11 K233945 ProxiDiagnost N90 / Precision CRF (706110, 706400) JAA Class II Radiology
2023-10-19 K232910 CombiDiagnost R90 JAA Class II Radiology
2021-12-13 K212186 Philips Radiology Smart Assistant KPR Class II Radiology
2021-09-21 K212837 ProxiDiagnost N90 JAA Class II Radiology
2021-04-02 K210692 DigitalDiagnost KPR Class II Radiology
2020-12-03 K203087 CombiDiagnost R90 JAA Class II Radiology
2020-09-30 K202564 DigitalDiagnost C90 MQB Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence