The Recall Desk

Hazard

Configuration Error recalls

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

What the numbers show

Total
18
Critical
0
Severe
0
Most recent
2026-03-18

Of the 18 configuration 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 0 (0%) 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 configuration 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.

1–18 of 18

  • HighFDA (Devices)·Z-1497-2026·2026-03-18

    IBA proton therapy system may not interrupt beam when gating fails

    Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.

    Product
    IBA Proton Therapy System - PROTEUS 235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2026·2026-02-18

    Display adapters recalled after the wrong configuration file was used

    Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.

    Product
    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2025·2024-10-23

    Horizon Cardiology Hemodynamic System Recalled for Configuration Error

    Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.

    Product
    Horizon Cardiology Hemo. Version 12.2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2025·2024-10-23

    Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall

    Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.

    Product
    Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2025·2024-10-16

    Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms

    Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.

    Product
    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indica
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3158-2024·2024-10-02

    Mobile X-Ray System Exposure Settings May Not Apply Correctly

    Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.

    Product
    The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2023·2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.

    Product
    Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2023·2023-02-01

    Abbott Alinity m System Nucleic Acid Testing Device Calibration Recall

    Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.

    Product
    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0197-2023·2022-11-16

    Orthopedic Surgical Blade Recall Due to Incorrect Configuration

    Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.

    Product
    Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0227-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle

    Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.

    Product
    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0754-2021·2021-01-06

    Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors

    Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.

    Product
    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2018·2018-08-01

    Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue

    Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.

    Product
    UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1145-2018·2018-03-28

    Merit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits

    Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.

    Product
    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2547-2016·2016-08-24

    Bard TruGuide Biopsy Needle Recall for Incorrect Stylet Configuration

    Bard Peripheral Vascular Inc is recalling 1,250 TruGuide Disposable Coaxial Biopsy Needles because some units may contain two trocar or two blunt tip stylets instead of one of each.

    Product
    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2015·2015-06-03

    Medrad Stellant CT Injector System Recalled for Under-Volume Hazard

    Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.

    Product
    MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1065-2014·2014-03-12

    Elekta Digital Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling 472 digital accelerators because customers are resetting default values outside recommended factory settings.

    Product
    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2014·2014-01-01

    Ziehm Vision RFD C-Arm X-Ray System Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

    Product
    Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide