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Philips 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Sunny Yi
EUDAMED SRN: US-MF-000002237
FDA FEI Number: 3017894900
DUNS Number: 063377717

Catalogue (456)

Page 4 of 10

Device	Model / Reference	Registries	Class	Status
Transducer S5-1	989605463921	FDA UDI	Class II	Active
XPERIUS Ultrasound System	989605467901	FDA UDI	Class II	Active
Affiniti 30 Ultrasound System	795218	FDA UDI	Class II	Active
Epiq 7c Diagnostic Ultrasound System	795201	FDA UDI	Class II	Active
EPIQ 7W Diagnostic Ultrasound System	795202	EUDAMEDFDA UDI	Class II	Active
Transducer C9-4	989605463491	FDA UDI	Class II	Active
Affiniti 70 Ultrasound Circular Edition	795119	FDA UDI	Class II	Active
EPIQ 5 Ultrasound System	795204	FDA UDI	Class II	Active
EPIQ 7 Diagnostic Ultrasound System	989605386721	FDA UDI	Class II	Active
Affiniti 50 Diagnostic Ultrasound System	795208	FDA UDI	Class II	Active
795122	00884838103252	FDA UDI	Class II	Active
Transducer X3-1	989605440742	FDA UDI	Class II	Active
QLAB Quantification Software	Release 10.8.5	FDA UDI	Class II	Active
S4-2 transducer	989605439582	FDA UDI	Class II	Active
Transducer C8-5	989605352343	FDA UDI	Class II	Active
SCNHD EnVisor L12-5 50mm	989605440932	FDA UDI	Class II	Active
Affiniti 30 Ultrasound Circular Edition	795121	FDA UDI	Class II	Active
Lumify Rugged System Bundle	989605477051	FDA UDI	Class II	Active
Lumify System Bundle	989605477201	FDA UDI	Class II	Active
ClearVue 850 Diagnostic Ultrasound System	989605428551	FDA UDI	Class II	Active
Transducer S3-1	989605361403	FDA UDI	Class II	Active
Clearvue 550 Ultrasound System	795094	FDA UDI	Class II	Active
ClearVue 580 Diagnostic Ultrasound System	989605416691	FDA UDI	Class II	Active
Lumify Rugged System Bundle	795007	FDA UDI	Class II	Active
ClearVue 350 Diagnostic Ultrasound System	989605388281	FDA UDI	Class II	Active
Xperius Ultrasound System	795101	FDA UDI	Class II	Active
EPIQ 7 Diagnostic Ultrasound System Circular Edition	795117	FDA UDI	Class II	Active
QLAB Advanced Quantification Software	989605492681	FDA UDI	Class II	Active
Lumify System Bundle	795006	FDA UDI	Class II	Active
Transducer VL13-5	989605372213	FDA UDI	Class II	Active
Lumify Diamond Select	795123	FDA UDI	Class II	Active
Transducer L10-4lap	989605395602	FDA UDI	Class II	Active
Sparq Ultrasound Circular Edition	795116	FDA UDI	Class II	Active
C6-3 Transducer	989605359594	FDA UDI	Class II	Active
CX Cart Circular Edition	989606745451	FDA UDI	Class II	Active
Transducer S7-2omni	989605440772	FDA UDI	Class II	Active
Affiniti 50 Diamond Select Ultrasound System	795118	FDA UDI	Class II	Active
Transducer L12-5 50	989605362313	FDA UDI	Class II	Active
Transducer L17-5	989605366373	FDA UDI	Class II	Active
Sparq Ultrasound Circular Edition	795116	FDA UDI	Class II	Active
EPIQ CVxi Diagnostic Ultrasound System	795232	EUDAMEDFDA UDI	Class II	Active
Cx50 Diamond Select System	795114	FDA UDI	Class II	Active
EPIQ Elite Diamond Select Ultrasound	795125	FDA UDI	Class II	Active
Epiq Cvx Diagnostic Ultrasound System	795231	EUDAMEDFDA UDI	Class II	Active
Lumify Diagnostic Ultrasound System iOS	795161	EUDAMEDFDA UDI	Class IIa	Active
EPIQ Elite Diagnostic Ultrasound System	795234	EUDAMEDFDA UDI	Class IIa	Active
EPIQ Elite Diagnostic Ultrasound System	795234	EUDAMEDFDA UDI	Class IIa	Active
Transducer L12-5	989605418552	EUDAMEDFDA UDI	Class IIa	Active
Transducer S7-3t	989605439232	EUDAMEDFDA UDI	Class IIa	Active
Transducer C9-4v	989605418972	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

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.