The Recall Desk

Hazard

Software Malfunction recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software malfunction 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.

51–75 of 109

  • HighFDA (Devices)·Z-1751-2024·2024-05-08

    RayStation radiation therapy planning system may report inaccurate dosimetry values

    RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.

    Product
    RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1501-2024·2024-04-24

    LifeVentEVO2 Ventilator Recalled for Potential Loss of Ventilation

    Philips Respironics is recalling the LifeVentEVO2 ventilator due to a software malfunction that can trigger a false Battery Depleted or Loss of Power alarm when power is sufficient, potentially causing sudden loss of ventilation.

    Product
    LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2024·2024-03-13

    Automated medication dispensing cabinets may randomly freeze, crash, or hang

    BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.

    Product
    BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0863-2024·2024-02-07

    Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects

    Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.

    Product
    smiths medical Medfusion Model 3500 Syringe pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0725-2024·2024-01-24

    Philips Spectral CT 7500 Recalled for Multiple Software Issues Affecting Functionality

    Philips is recalling 197 Spectral CT 7500 computed tomography systems due to multiple software issues affecting device functionality. The devices were distributed nationwide and internationally.

    Product
    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2024·2023-12-20

    Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results

    Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.

    Product
    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2024·2023-12-20

    Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays

    The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.

    Product
    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2024·2023-12-20

    Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays

    Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.

    Product
    VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2024·2023-12-20

    Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.

    Product
    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2024·2023-12-20

    Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy

    SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.

    Product
    SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0319-2024·2023-11-22

    CT Scanner Software Bug May Cause Gantry to Move to Wrong Position

    Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2023·2023-10-11

    Philips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues

    Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.

    Product
    Incisive CT, software version 5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2023·2023-10-04

    Baxter Epiphany Cardio Server E3 Caliper Tool Non-Responsive in ECG System

    Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.

    Product
    Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2023·2023-07-05

    Virtual reality therapy device software malfunction prevents treatment progression

    RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.

    Product
    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2045-2023·2023-07-05

    Mobile Digital X-Ray System Recall: Software Login Issue Affects Units

    SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.

    Product
    wDR 2.2 Mobile Digital Diagnostic X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2023·2023-03-22

    Arial mobile application recalled for Android loading failures

    Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.

    Product
    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2023·2023-03-22

    Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold

    Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.

    Product
    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2023·2023-03-15

    Radiation Therapy System Software Issue May Cause Unexpected Dose

    Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.

    Product
    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0911-2023·2023-01-18

    Neurostimulation Clinician Programmer Software Anomalies Affecting Device Control

    Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0912-2023·2023-01-18

    Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall

    Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0719-2023·2022-12-21

    Oncentra Brachy Radiation Therapy Software Reconstruction Error

    Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.

    Product
    Oncentra Brachy radiation therapy planning system software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2022·2022-10-05

    t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

    Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states