The Recall Desk

Manufacturer

Philips Ultrasound, Inc.

132 recalls in our database name Philips Ultrasound, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
132
Critical
0
Severe
3
Most recent
2026-04-01

Of the 132 recalls from Philips Ultrasound, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 132

  • HighFDA (Devices)·Z-1757-2024·2024-05-15

    Philips 5000 Compact Series Ultrasound Systems pose uncontrolled burn risk

    Philips 5000 Compact Series ultrasound systems may leave unselected transesophageal transducers powered without temperature monitoring, risking patient burns during imaging procedures.

    Product
    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 with multiport adapters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2024·2023-11-15

    Philips Affiniti 70 Ultrasound System Software Defect May Cause Delayed Images

    Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.

    Product
    Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0283-2024·2023-11-15

    Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images

    Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.

    Product
    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 (model # 795234)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2517-2023·2023-09-13

    Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect

    Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.

    Product
    3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2022·2021-10-27

    Philips EPIQ CVxi Ultrasound Systems Software Issue Causes System Unresponsiveness

    Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.

    Product
    EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0070-2022·2021-10-13

    Philips Sparq Diagnostic Ultrasound System Battery Shutdown Issue

    Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2022·2021-10-13

    Philips Ultrasound Sparq System Recalled Due to Intermittent Shutdown Risk

    Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2021·2021-09-29

    Philips EPIQ Ultrasound Systems Recalled for Software Lock-up Defect

    Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2021·2021-09-29

    Philips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams

    Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.

    Product
    Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2021·2021-08-25

    Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail

    Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.

    Product
    EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2021·2021-02-10

    Philips EPIQ Ultrasound Systems Recalled for Inaccurate Doppler Flow Visualization

    Philips is recalling EPIQ Diagnostic Ultrasound Systems because the Image Boost feature may cause inaccurate color and Doppler flow visualization when used with specific transducers.

    Product
    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 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-2
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0947-2021·2021-02-10

    Philips EPIQ Ultrasound Systems Recalled for Control Panel Failure Risk

    Philips is recalling 12,080 EPIQ Diagnostic Ultrasound Systems because the control panel arm assembly may break off if subjected to undue force.

    Product
    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 guidance during treatment of cardiovascular disease in which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2021·2021-01-20

    Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors

    Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.

    Product
    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 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1843-2020·2020-05-13

    Philips TEE Transducers Recalled Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocard
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    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 body - particularly transesophageal echocardiography (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2020·2020-05-13

    Philips S8-3t Transesophageal Ultrasound Transducers Recalled for Temperature Measurement Failure

    Philips is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2019·2019-08-14

    Philips Ultrasound Systems Recalled for Patient Data Entry Error

    Philips is recalling EPIQ and Affiniti ultrasound systems with software version 4.0 because patient images may be moved to the wrong folder.

    Product
    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 the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2016·2016-04-20

    Philips EPIQ Ultrasound Systems Recalled for Control Panel Fastener Loosening

    Philips is recalling EPIQ diagnostic ultrasound systems because fasteners securing the control panel may loosen, potentially causing the assembly to detach.

    Product
    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 pediatric, cerebral vascular, cephalic (adult), cephalic (neonata
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2016·2016-01-13

    Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error

    Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.

    Product
    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1807-2015·2015-06-24

    Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues

    Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.

    Product
    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 quantitative image data from ultrasound exams. It is desig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2015·2015-05-27

    Philips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations when using Metric settings.

    Product
    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 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2015·2015-05-27

    Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error

    Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1579-2015·2015-05-13

    Philips EPIQ 7 Ultrasound System Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 7 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (
    Category
    Medical Device
    Distribution
    Distributed nationwide