Data / Medical devices / United States / Philips Ultrasound LLC
Philips Ultrasound LLC: FDA-registered device maker in Bothell, WA, United States, 90 510(k) clearances
Philips Ultrasound LLC is registered with the FDA (registration 3019216) in Bothell, WA, United States. It lists 9 device types. The FDA files 90 510(k) clearances under its listings, the newest dated September 25, 2026. 29 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019216
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, United States, 98021
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 12L5A Linear Array Transduce, 12L5A Linear Array Transducer, 21221B (C1914C), 21223B (D5014V), 21228B (D1914V), 21321A (C3540), 21330A (S4), 21350A (S8) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| August 4, 2026 | K262311 | Alturion Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| July 27, 2026 | K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| June 29, 2026 | K260667 | Alturion Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 27, 2026 | K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 27, 2026 | K260123 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 5, 2026 | K252558 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| March 27, 2026 | K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| December 22, 2025 | K252557 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 9, 2025 | K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| July 24, 2025 | K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| June 18, 2025 | K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 21, 2025 | K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 15, 2025 | K242519 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 9, 2025 | K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 8, 2025 | K242670 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| April 28, 2025 | K250030 | Flash Ultrasound System 5100 Point of Care | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| April 10, 2025 | K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| March 6, 2025 | K243331 | LVivo Seamless | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| February 10, 2025 | K241659 | Ultrasound Workspace (UWS 6.0) | QIH | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| February 6, 2025 | K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| December 12, 2024 | K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| November 15, 2024 | K242800 | The 5000 Compact Series Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 7, 2024 | K240980 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| April 24, 2024 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| February 13, 2024 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| November 30, 2023 | K233545 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| October 26, 2023 | K232500 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| May 12, 2023 | K231190 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| May 4, 2023 | K223771 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound | accessdata.fda.gov |
| January 18, 2023 | K223804 | PercuNav Image Fusion and Interventional Navigation System | JAK | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| September 27, 2022 | K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | IYN | Substantially Equivalent | Philips Ultrasound, LLC | accessdata.fda.gov |
| January 6, 2022 | K213544 | TOMTEC-ARENA | QIH | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| September 24, 2021 | K212777 | Collaboration Live | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 24, 2021 | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 8, 2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| February 23, 2021 | K203406 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 20, 2020 | K200603 | AAA Model | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 15, 2020 | K201665 | Collaboration Live | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| September 2, 2020 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 17, 2020 | K201352 | 3D Auto LAA | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| August 14, 2020 | K201632 | TOMTEC-ARENA | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| June 3, 2020 | K200974 | QLAB Advanced Quantification Software | QIH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| May 14, 2020 | K201053 | PercuNav Image Fusion and Interventional Navigation | JAK | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| May 1, 2020 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 6, 2020 | K200304 | EPIQ Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 18, 2020 | K200179 | Collaboration Live | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| December 20, 2019 | K191647 | QLAB Advanced Quantification Software | QIH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| September 6, 2019 | K192226 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 18, 2019 | K190913 | QLAB Advanced Quantification Software 13 | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| November 9, 2018 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 23, 2018 | K182529 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 7, 2018 | K181264 | QLAB Advanced Quantification Software | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 13, 2017 | K172056 | InnoSight Diagnostic Ultrasound System | IYO | Substantially Equivalent | Qisda Corporation | accessdata.fda.gov |
| October 4, 2017 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| May 30, 2017 | K171314 | QLAB Advanced Quantification Software | LLZ | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 21, 2017 | K170716 | PercuNav Image Fusion and Interventional Navigation | JAK | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 10, 2017 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| November 16, 2016 | K163020 | Xperius Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 3, 2016 | K162549 | Lumify Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| September 14, 2016 | K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 6, 2016 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 16, 2015 | K153480 | ClearVue850 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| October 30, 2015 | K152899 | Philips Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Healthcare, Inc. | accessdata.fda.gov |
| May 9, 2015 | K150533 | Terason uSmart3200T Ultrasound System | IYN | Substantially Equivalent | Teratech Corp. | accessdata.fda.gov |
| February 20, 2015 | K150148 | Terason uSmart3300 Ultrasound System | IYN | Substantially Equivalent | Teratech Corp. | accessdata.fda.gov |
| February 13, 2015 | K150122 | TOMTEC-ARENA TTA2 | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| July 2, 2014 | K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140808 | Q-STATION | LLZ | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| August 21, 2013 | K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 24, 2013 | K132087 | PERCUNAV SYSTEM | JAK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 18, 2013 | K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 17, 2012 | K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 24, 2011 | K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 8, 2011 | K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| February 1, 2010 | K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 17, 2009 | K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| July 11, 2008 | K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| June 24, 2008 | K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| December 14, 2006 | K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Medison Co., Ltd. | accessdata.fda.gov |
| August 18, 2006 | K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 6, 2005 | K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 4, 2004 | K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 8, 2004 | K034003 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| March 13, 2003 | K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| January 7, 2002 | K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 | IYN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| June 18, 1999 | K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Advanced Technology Laboratories, Inc. | accessdata.fda.gov |
| February 18, 1999 | K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | IYN | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | 99878 | Class I | Ongoing | Philips Lumify Diagnostic Ultrasound System | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/, there may be an unstable connection/may disconnect disrupting function. May caus | accessdata.fda.gov |
| August 7, 2026 | 99706 | Class II | Ongoing | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 | Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis. | accessdata.fda.gov |
| October 31, 2025 | 97843 | Class II | Ongoing | Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841 | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. | accessdata.fda.gov |
| March 23, 2024 | 94328 | Class II | Ongoing | 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come | Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in t | accessdata.fda.gov |
| October 9, 2023 | 93218 | Class II | Completed | Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (mo | Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image. | accessdata.fda.gov |
| June 30, 2023 | 92761 | Class II | Completed | 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000 | Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail. | accessdata.fda.gov |
| July 14, 2022 | 98102 | Class II | Completed | Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF:,, 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122 | Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. | accessdata.fda.gov |
| September 21, 2021 | 88728 | Class II | Terminated | EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 | Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system butto | accessdata.fda.gov |
| August 19, 2021 | 88625 | Class II | Terminated | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only | Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power. | accessdata.fda.gov |
| August 6, 2021 | 88514 | Class II | Completed | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231 | Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. | accessdata.fda.gov |
| July 22, 2021 | 88313 | Class II | Completed | EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi | Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury. | accessdata.fda.gov |
| December 24, 2020 | 87156 | Class II | Terminated | Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image | Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off. | accessdata.fda.gov |
| December 16, 2020 | 87012 | Class II | Terminated | Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DI | The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fl | accessdata.fda.gov |
| October 27, 2020 | 86992 | Class II | Terminated | All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100 | The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software. | accessdata.fda.gov |
| August 30, 2019 | 84902 | Class II | Terminated | Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human b | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in pati | accessdata.fda.gov |
| April 29, 2019 | 83003 | Class II | Terminated | Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of | There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device. | accessdata.fda.gov |
| March 28, 2016 | 73665 | Class II | Terminated | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatri | The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system. | accessdata.fda.gov |
| December 9, 2015 | 72879 | Class II | Terminated | Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) | Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in | accessdata.fda.gov |
| May 15, 2015 | 71432 | Class II | Terminated | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and qu | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients. | accessdata.fda.gov |
| April 14, 2015 | 71105 | Class II | Terminated | EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 | When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA). | accessdata.fda.gov |
| April 10, 2015 | 71084 | Class II | Terminated | EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 45 | When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). | accessdata.fda.gov |
| November 5, 2014 | 69790 | Class II | Terminated | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************** | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and | accessdata.fda.gov |
| July 9, 2014 | 68756 | Class II | Terminated | QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. | accessdata.fda.gov |
| April 25, 2007 | 37888 | Not yet classified | Terminated | HD11XE Diagnostic Ultrasound System | Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen | accessdata.fda.gov |
| November 2, 2006 | 36722 | Not yet classified | Terminated | iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic) | Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode) | accessdata.fda.gov |
| May 13, 2005 | 32196 | Not yet classified | Terminated | Envisor, M2540 Diagnostic Ultrasound System | A defect in the software allows incorrect measurement results to be entered into the system's built-in report. | accessdata.fda.gov |
| May 6, 2005 | 32064 | Not yet classified | Terminated | Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) | The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI. | accessdata.fda.gov |
| February 24, 2005 | 33411 | Not yet classified | Terminated | Optimus 30 | Systems do not comply with the labeling performance standards. | accessdata.fda.gov |
| September 10, 2004 | 30160 | Not yet classified | Terminated | HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system). | Potential for device to cause burning of the skin. | accessdata.fda.gov |
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Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.