The Recall Desk

Hazard

Treatment Error recalls

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

What the numbers show

Total
20
Critical
0
Severe
3
Most recent
2024-02-28

Of the 20 treatment error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (15%) 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 treatment error 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.

1–20 of 20

  • HighFDA (Devices)·Z-1172-2024·2024-02-28

    Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis

    FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.

    Product
    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error

    Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2023·2023-05-10

    Laboratory Automation Module Firmware May Cause Sample Misidentification

    Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.

    Product
    Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2023·2023-04-26

    Beckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results

    Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.

    Product
    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2022·2021-11-03

    Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters

    Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.

    Product
    Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2021·2021-09-15

    Proteus 235 Proton Therapy System May Display Misleading Popup Message

    Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.

    Product
    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2019·2019-06-26

    CIVCO Solstice SRS Immobilization System Recalled for Potential Movement

    Med Tec Inc is recalling 28 units of the CIVCO Solstice SRS Immobilization System because the device may move during patient setup or treatment.

    Product
    CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2019·2019-04-17

    Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues

    Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2019·2018-10-10

    Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur without intended respiratory gating.

    Product
    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    Product
    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2592-2017·2017-06-28

    Ion Beam Applications Recalls Proteus 235 Medical Devices

    Ion Beam Applications S.A. is recalling 18 Proteus 235 systems due to potential dark current issues in Pencil Beam Scanning mode.

    Product
    Proteus 235
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0731-2017·2016-12-21

    Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error

    Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.

    Product
    MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2016·2016-09-07

    Elekta Monaco RTP System Software Recall for Contour Deletion Error

    Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.

    Product
    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2195-2015·2015-07-29

    Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

    Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

    Product
    GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1954-2015·2015-07-08

    ViewRay Treatment Planning Software Recalled for Location Calculation Failure

    ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.

    Product
    Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2574-2014·2014-09-10

    Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch

    Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.

    Product
    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2014·2014-02-12

    Elekta XiO RTP System Recalled for Incorrect Effective Depth Calculation

    Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.

    Product
    XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide