The Recall Desk

Hazard

Incorrect Treatment recalls

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

What the numbers show

Total
22
Critical
0
Severe
5
Most recent
2024-08-14

Of the 22 incorrect treatment recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (23%) 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 treatment 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.

1–22 of 22

  • HighFDA (Devices)·Z-2510-2024·2024-08-14

    Philips IntelliVue Patient Monitors lack critical software monitoring options

    Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.

    Product
    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2021·2021-01-20

    Philips Emission Computed Tomography System Software Defect Recall

    Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.

    Product
    Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2020·2020-03-18

    BioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results

    BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.

    Product
    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0203-2019·2018-10-31

    Data Innovations Recalls Abbott Alinity ci-series Software Driver

    Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.

    Product
    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2746-2018·2018-08-22

    Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems

    Mevion Medical Systems is recalling seven MEVION S250 and S250i proton beam therapy systems due to unauthorized accessory combinations that may cause patient injury.

    Product
    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2018·2018-03-14

    Philips IQon Spectral CT Software Recall for Image Misrepresentation

    Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.

    Product
    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0829-2018·2018-03-07

    Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly

    Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.

    Product
    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2018·2017-12-20

    Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping

    Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.

    Product
    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2018·2017-12-06

    BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures

    Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.

    Product
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-3110-2017·2017-09-13

    Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error

    Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.

    Product
    MOSAIQ Medical Charged-Particle Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2017·2017-05-24

    BioMerieux Recalls ETEST ETP32 Ertapenem Strips Due to False Results

    BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.

    Product
    ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2017·2017-01-25

    Fresenius 2008K Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.

    Product
    Fresenius 2008K Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2016·2016-01-13

    Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

    Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

    Product
    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1282-2015·2015-03-25

    Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors

    Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.

    Product
    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2015·2015-02-11

    Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces

    Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.

    Product
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2733-2014·2014-10-08

    Lumenis Array LaserLink Recall for Erroneous Retinal Pattern Display

    Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.

    Product
    Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2014·2014-07-23

    Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

    Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

    Product
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2014·2014-04-02

    Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error

    Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.

    Product
    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2013·2013-04-24

    GE Healthcare Recalls Muse v7 Cardiology System Due to Medication Display Error

    GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.

    Product
    GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd.
    Category
    Medical Device
    Distribution
    1 state