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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 1 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alturion Diagnostic Ultrasound System | 795419 | EUDAMED | Class IIa | Active |
| EPIQ Series Diagnostic Ultrasound System | K260123 | FDA 510(k) | Class II | Active |
| EPIQ Series Diagnostic Ultrasound Systems | K260680 | FDA 510(k) | Class II | Active |
| Qlab Quantification Software | K132165 | FDA 510(k) | Class II | Active |
| Sparq Diamond Select System | 795116 | FDA UDI | Class II | Active |
| Transducer C9-3io | 989605395612 | FDA UDI | Class II | Active |
| XPERIUS Ultrasound System | 989605452211 | FDA UDI | Class II | Active |
| Transducer C8-4v | 989605408153 | FDA UDI | Class II | Active |
| EPIQ 5 Diamond Select Ultrasound System | 795120 | FDA UDI | Class II | Active |
| Transducer S12-4 | 989605361973 | FDA UDI | Class II | Active |
| EPIQ 5 Diagnostic Ultrasound System | 989605408541 | FDA UDI | Class II | Active |
| Transducer 5.0 CW | 989605440662 | FDA UDI | Class II | Active |
| Transducer L12-5 38 | 989605428532 | FDA UDI | Class II | Active |
| Transducer C9-4ec | 300013145921 | FDA UDI | Class II | Active |
| ClearVue 550 Diagnostic Ultrasound System | 989605409201 | FDA UDI | Class II | Active |
| ClearVue 650 Diagnostic Ultrasound System | 989605414681 | FDA UDI | Class II | Active |
| Transducer X7-2 | 989605463501 | FDA UDI | Class II | Active |
| Clearvue 850 Diagnostic Ultrasound System | 795226 | FDA UDI | Class II | Active |
| Transducer 3D8-4 | 989605345333 | FDA UDI | Class II | Active |
| Transducer S12-4 | 989605440782 | FDA UDI | Class II | Active |
| 063377717 | 063377717 | FDA UDI | Class II | Active |
| QLAB Quantification Software | Release 10.7 | FDA UDI | Class II | Active |
| Transducer C8-5 | 989605440822 | FDA UDI | Class II | Active |
| EPIQ CVx Ultrasound Circular Edition | 795122 | FDA UDI | Class II | Active |
| EPIQ CVx Diagnostic Ultrasound System Circular Edition | 795122 | FDA UDI | Class II | Active |
| Transducer L12-4 | 989605418963 | FDA UDI | Class II | Active |
| Affiniti CVx Diagnostic Ultrasound System | 795190 | FDA UDI | Class II | Active |
| Transducer S8-3 | 989605440752 | FDA UDI | Class II | Active |
| Transducer L8-4 | 989605440812 | FDA UDI | Class II | Active |
| EPIQ Elite Ultrasound Circular Edition | 795125 | FDA UDI | Class II | Active |
| Transducer L12-3 | 989605348243 | FDA UDI | Class II | Active |
| Affiniti 70 Ultrasound System | 795210 | FDA UDI | Class II | Active |
| Transducer T6207 | 989605439242 | FDA UDI | Class II | Active |
| Transducer S4-2 | 989605430222 | FDA UDI | Class II | Active |
| Transducer L11-3 | 989605400513 | FDA UDI | Class II | Active |
| Transducer C9-4 | 989605365023 | FDA UDI | Class II | Active |
| iE33 Diagnostic Ultrasound System | 8500-0082-01 | FDA UDI | Class II | Active |
| Affiniti 30 Diagnostic Ultrasound System | 989605457591 | FDA UDI | Class II | Active |
| Transducer S12 | 989605362014 | FDA UDI | Class II | Active |
| C5-2 transducer | 989605439592 | FDA UDI | Class II | Active |
| Transducer C8-4v | 989803002685 | FDA UDI | Class II | Active |
| Affiniti 70 Diagnostic Ultrasound System Circular Edition | 795119 | FDA UDI | Class II | Active |
| Sparq Ultrasound System | 795090 | FDA UDI | Class II | Active |
| Transducer C5-2 | 989605454101 | FDA UDI | Class II | Active |
| Transducer S4-1 | 989605364993 | FDA UDI | Class II | Active |
| Affiniti 30 Diamond Select Ultrasound System | 795121 | FDA UDI | Class II | Active |
| EPIQ 5W Ultrasound System | 795206 | FDA UDI | Class II | Active |
| Qlab Quantification Software | 989606710071 | FDA UDI | Class II | Active |
| EPIQ CVxi Diagnostic Ultrasound System | 795232 | FDA UDI | Class II | Active |
| VISIQ Diagnostic Ultrasound System | 989605414421 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
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Authorities
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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. |