← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 5 of 10
DeviceModel / ReferenceRegistriesClassStatus
Transducer C5-2 989605450353
EUDAMEDFDA UDI
Class IIaActive
Transducer L12-4 989605477121
EUDAMEDFDA UDI
Class IIaActive
Premium Compact Cart, Spanish 989606735241
EUDAMEDFDA UDI
Class IActive
Transducer L15-7io, Variant 2 989605391083
EUDAMEDFDA UDI
Class IIaActive
Transducer X5-1, Variant 4 989605466001
EUDAMEDFDA UDI
Class IIaActive
40002 PercuNav Coaxial Needle Tracker, 13Gx16cm 989605427994
EUDAMEDFDA UDI
Class IIaActive
Transducer X6-1 989605409282
EUDAMEDFDA UDI
Class IIaActive
21001 PercuNav Endocavity Ultrasound Tracker 989605435122
EUDAMEDFDA UDI
Class IActive
Transducer C9-4v, Variant 1 989605389252
EUDAMEDFDA UDI
Class IIaActive
Premium Compact Cart, German 989606735201
EUDAMEDFDA UDI
Class IActive
Transducer L15-7io 989605387852
EUDAMEDFDA UDI
Class IIaActive
Deluxe Compact Cart, English 989606735071
EUDAMEDFDA UDI
Class IActive
Transducer L12-3 989605412072
EUDAMEDFDA UDI
Class IIaActive
Extended Compact Cart, Russian 989606735061
EUDAMEDFDA UDI
Class IActive
Transducer 3D9-3v Variant 2 989605415032
EUDAMEDFDA UDI
Class IIaActive
EPIQ Elite Diagnostic Ultrasound System 795125
EUDAMEDFDA UDI
Class IIaActive
40003 PercuNav Coaxial Needle Tra cker, 16Gx11cm 989605428004
EUDAMEDFDA UDI
Class IIaActive
Extended Compact Cart, Danish 989606734971
EUDAMEDFDA UDI
Class IActive
Transducer C5-2 989605477131
EUDAMEDFDA UDI
Class IIaActive
Transducer L18-5 989605409582
EUDAMEDFDA UDI
Class IIaActive
Transducer C5-2 PUC, Variant 8 989605371713
EUDAMEDFDA UDI
Class IIaActive
Deluxe Compact Cart, German 989606735081
EUDAMEDFDA UDI
Class IActive
Flash Ultrasound System 5100 POC 795404
EUDAMEDFDA UDI
Class IIaActive
Transducer X7-2t 989605350454
EUDAMEDFDA UDI
Class IIaActive
Lumify Rugged System Bundle 795007
EUDAMEDFDA UDI
Class IIaActive
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K251110
FDA 510(k)
Class IIActive
Hd11 Diagnostic Ultrasound System K062247
FDA 510(k)
Class IIActive
Q-Station K103815
FDA 510(k)
Class IIActive
Hdi 5000 Diagnostic Ultrasound System K034003
FDA 510(k)
Class IIActive
Philips M2424 Diagnostic Ultrasound System &philips 21315 Diagnostic Ultrasound Transducer K022303
FDA 510(k)
Class IIActive
PercuNav Image Fusion and Interventional Navigation K201053
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K243794
FDA 510(k)
Class IIActive
Nuvis Diagnostic Ultrasound System K133833
FDA 510(k)
Class IIActive
Boris Platform Diagnostic Ultrasound System K030455
FDA 510(k)
Class IIActive
The 5000 Compact Series Ultrasound Systems K242800
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K240850
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound System K240980
FDA 510(k)
Class IIActive
Sdr 3500 (philips Platinum +) K873937
FDA 510(k)
Class IIActive
Collaboration Live K212777
FDA 510(k)
Class IIActive
Cx50 Diagnostic Ultrasound System K081802
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K253595
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K243793
FDA 510(k)
Class IIActive
Visiq Diagnostic Ultra Sound System K141369
FDA 510(k)
Class IIActive
Ultrasound Workspace (UWS 6.0) K241659
FDA 510(k)
Class IIActive
Hd15 Diagnostic Ultrasound System K081661
FDA 510(k)
Class IIActive
Philips Iu22 Ultrasound System K042540
FDA 510(k)
Class IIActive
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System K251651
FDA 510(k)
Class IIActive
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System K181485
FDA 510(k)
Class IIActive
Q Lab Quantification Software With Strain Rate Quantification Plug-In K023877
FDA 510(k)
Class IIActive
Qlab 8.1 Quantification Software K110414
FDA 510(k)
Class IIActive

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.

DateRecall No.ClassStatusReason
Oct 31, 2025Z-0883-2026—open, classified

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Sep 5, 2025Z-1621-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1624-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1627-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1626-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1619-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1628-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1618-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1622-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1625-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1620-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Sep 5, 2025Z-1623-2026—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2352-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2406-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2379-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2395-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2359-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2351-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2398-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2397-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2407-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2409-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2354-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2383-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2381-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2403-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2377-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2390-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2389-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2371-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2394-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2380-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2363-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2374-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2401-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2356-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2386-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2372-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2357-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2348-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2369-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2366-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2392-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2385-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2382-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2370-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2376-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2404-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2396-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2362-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2350-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2368-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2358-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2349-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2365-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2400-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2361-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2367-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2388-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2391-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2346-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2408-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2399-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2384-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2355-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2414-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2378-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2375-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2405-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2412-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2353-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2413-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2360-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2387-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2410-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2347-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2393-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2364-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2411-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2402-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025Z-2373-2025—open, classified

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

May 28, 2025Z-2052-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2067-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2060-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2058-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2062-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2061-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2051-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2054-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2057-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2064-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2066-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2068-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2056-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2048-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2049-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2055-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2059-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2050-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025Z-2065-2025—open, classified

Ultrasound transducer devices were refurbished beyond their useful life.