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.

126–132 of 132

  • HighFDA (Devices)·Z-1578-2015·2015-05-13

    Philips EPIQ 5 Ultrasound Systems Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    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) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2015·2014-12-24

    Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations

    Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.

    Product
    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. *********************************************************************************** Devices identified in the Field Safety
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0816-2015·2014-12-24

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.

    Product
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0817-2015·2014-12-24

    Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect therapy.

    Product
    EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0818-2015·2014-12-24

    Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements

    Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.

    Product
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2109-2014·2014-07-30

    Philips QLAB 10 Core Module Software Recall for Measurement Defect

    Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.

    Product
    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.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2110-2014·2014-07-30

    Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

    Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

    Product
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states