The Recall Desk

Hazard

Incorrect Therapy recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2014-12-24

Of the 6 incorrect therapy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (17%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incorrect therapy recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • 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-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-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-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1797-2013·2013-07-31

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.

    Product
    Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support
    Category
    Medical Device
    Distribution
    Distributed nationwide