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Sign in to claim this brandPhilips Ultrasound LLC
United States·US-MF-000002237
Last updated September 17, 2026
What Philips Ultrasound LLC makes
Philips Ultrasound LLC manufactures general-purpose ultrasound imaging systems, including diagnostic and surgical transducers, as well as specialized neurological and multi-purpose stereotactic surgery systems. Their portfolio also includes radiological picture archiving and communication system (PACS) software, electromechanical transport trolleys, and reusable electrical connection cables for medical devices.
The company’s devices are regulated under Class I, Class II, and Class IIa classifications, with listings in the EU’s eudamed registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 22100, Bothell Everett Highway, Bothell, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Sunny Yi
- EUDAMED SRN
- US-MF-000002237
- FDA FEI Number
- 3017894900
- DUNS Number
- 063377717
Catalogue (456)
Page 8 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Transducer BP10-5ec | 989605366703 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer C8-4v, Variant 5 | 989605368833 | EUDAMEDFDA UDI | Class IIa | Active |
| 10001 PercuNav Patient Tracker | 989605427133 | EUDAMEDFDA UDI | Class I | Active |
| Affiniti 70 Diagnostic Ultrasound System | 795210 | EUDAMEDFDA UDI | Class IIa | Active |
| EPIQ 7 Diagnostic Ultrasound System | 795117 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti 50 Diagnostic Ultrasound System | 795118 | EUDAMEDFDA UDI | Class IIa | Active |
| Deluxe Compact Cart, Swedish | 989606735111 | EUDAMEDFDA UDI | Class I | Active |
| EPIQ Diagnostic Ultrasound System | 795122 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer C5-2, Variant 4 | 989605463361 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer C5-2, Variant 11 | 989605451181 | EUDAMEDFDA UDI | Class IIa | Active |
| Extended Compact Cart, Spanish | 989606734991 | EUDAMEDFDA UDI | Class I | Active |
| Premium Compact Cart, Chinese | 989606735371 | EUDAMEDFDA UDI | Class I | Active |
| 40001 PercuNav Coaxial Needle Tracker, 13Gx11cm | 989605427984 | EUDAMEDFDA UDI | Class IIa | Active |
| Deluxe Compact Cart, Portuguese | 989606735321 | EUDAMEDFDA UDI | Class I | Active |
| Extended Compact Cart, Italian | 989606735021 | EUDAMEDFDA UDI | Class I | Active |
| Transducer S4-1 | 989605458222 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti CVx Diagnostic Ultrasound System | 795190 | EUDAMEDFDA UDI | Class IIa | Active |
| Extended Compact Cart, Japan | 989606735041 | EUDAMEDFDA UDI | Class I | Active |
| Tomtec-Arena | 795103 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer C10-4ec | 989605413712 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer 3D9-3v, Variant 3 | 989605440832 | EUDAMEDFDA UDI | Class IIa | Active |
| Deluxe Compact Cart, Chinese | 989606735361 | EUDAMEDFDA UDI | Class I | Active |
| Ultrasound System 5300 | 795148 | EUDAMEDFDA UDI | Class IIa | Active |
| EPIQ 5 Diagnostic Ultrasound System | 795204 | EUDAMEDFDA UDI | Class IIa | Active |
| Flash Ultrasound System 5100 POC Pro | 795158 | EUDAMEDFDA UDI | Class IIa | Active |
| Extended Compact Cart, French | 989606734961 | EUDAMEDFDA UDI | Class I | Active |
| Transducer L12-3 ERGO | 453562115561 | EUDAMED | Class IIa | Active |
| Transducer X5-1, Variant 5 | 989605466021 | EUDAMEDFDA UDI | Class IIa | Active |
| EPIQ 5 Diagnostic Ultrasound System | 795120 | EUDAMEDFDA UDI | Class IIa | Active |
| EPIQ 7 Diagnostic Ultrasound System | 795117 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti 70 Diagnostic Ultrasound System | 795210 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti 70 Diagnostic Ultrasound System | 795210 | EUDAMED | Class IIa | Active |
| EPIQ 5 Diagnostic Ultrasound System | 795120 | EUDAMEDFDA UDI | Class IIa | Active |
| Lumify Power Module | 453561998453 | EUDAMEDFDA UDI | Class I | Active |
| Ultrasound System 5500 | 795143 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer eL18-4 EMT | 989605431531 | EUDAMEDFDA UDI | Class IIa | Active |
| Premium Compact Cart, Finnish | 989606735301 | EUDAMEDFDA UDI | Class I | Active |
| Transducer C5-2, Variant 10 | 989605463351 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer L12-4, Variant 3 | 989605434812 | EUDAMEDFDA UDI | Class IIa | Active |
| Premium Compact Cart, Portuguese | 989606735281 | EUDAMEDFDA UDI | Class I | Active |
| Affiniti CVx Diagnostic Ultrasound System | 795190 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer D5cwc | 989605412062 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti 30 Diagnostic Ultrasound System | 795218 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer D2cwc | 989605412052 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer S8-3, Variant 3 | 989605361963 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer C8-5 | 989605391922 | EUDAMEDFDA UDI | Class IIa | Active |
| Ultrasound Workspace | 300013759461 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer 3D9-3v | 989605395622 | EUDAMEDFDA UDI | Class IIa | Active |
| Affiniti CVx Diagnostic Ultrasound System | 795190 | EUDAMEDFDA UDI | Class IIa | Active |
| 40009 PercuNav Coaxial Needle Tracker, 20Gx17cm | 989605428064 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Philips Ultrasound LLC has initiated 139 recall records between September 10, 2004, and October 31, 2025, with statuses including completed, open, classified, and terminated. The recalls involve issues such as inaccurate fluid flow visualization, unit conversion errors affecting Body Surface Area (BSA) calculations, potential software lock-ups, mechanical failures in control panel assemblies, and incorrect acoustic index displays. Additional concerns include software defects causing incorrect patient data storage, non-compliance with labeling performance standards, and battery system shutdowns. Some records address transducer labeling clarifications and discrepancies in automated cardiac measurements.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 31, 2025 | Z-0883-2026 | — | open, classified | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. |
| Sep 5, 2025 | Z-1621-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1624-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1627-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1626-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1619-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1628-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1618-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1622-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1625-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1620-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Sep 5, 2025 | Z-1623-2026 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2352-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2406-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2379-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2395-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2359-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2351-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2398-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2397-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2407-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2409-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2354-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2383-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2381-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2403-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2377-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2390-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2389-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2371-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2394-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2380-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2363-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2374-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2401-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2356-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2386-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2372-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2357-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2348-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2369-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2366-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2392-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2385-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2382-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2370-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2376-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2404-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2396-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2362-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2350-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2368-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2358-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2349-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2365-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2400-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2361-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2367-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2388-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2391-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2346-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2408-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2399-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2384-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2355-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2414-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2378-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2375-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2405-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2412-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2353-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2413-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2360-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2387-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2410-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2347-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2393-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2364-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2411-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2402-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Z-2373-2025 | — | open, classified | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Z-2052-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2067-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2060-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2058-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2062-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2061-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2051-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2054-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2057-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2064-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2066-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2068-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2056-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2048-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2049-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2055-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2059-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2050-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Z-2065-2025 | — | open, classified | Ultrasound transducer devices were refurbished beyond their useful life. |