The Recall Desk

Hazard

Software Defect recalls

1,335 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,335
Critical
14
Severe
91
Most recent
2026-09-09

Of the 1,335 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 91 (7%) 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 software defect 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.

501–525 of 1335

  • ModerateFDA (Devices)·Z-1345-2020·2020-03-04

    Philips DigiTrak XT Holter Recorder Software Recall for Malfunction

    Philips is recalling DigiTrak XT Holter Recorders because a software defect causes the device to fail when an AAA battery is present.

    Product
    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Config
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0947-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropri
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0952-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.

    Product
    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0950-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the app
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0942-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0951-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling three Trilogy EVO Ventilators in Italy because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0953-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0945-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.

    Product
    Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accesso
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0946-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.

    Product
    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acces
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0948-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.

    Product
    Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0954-2020·2020-02-26

    Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate access
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0949-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling five Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0943-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1330-2020·2020-02-26

    Mindray DP-30 Ultrasound Systems Recalled for Incorrect Needle-Guide Display

    Mindray is recalling 53 DP-30 ultrasound systems and 18 USB drives because the devices display an incorrect needle-guide bracket when used with a specific transducer.

    Product
    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small org
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2020·2020-02-19

    Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors

    Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.

    Product
    ROSA Brain 3.0 Application-Brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2020·2020-02-19

    Philips VesselNavigator Software Recall for DSA Display Defect

    Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.

    Product
    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extension
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2020·2020-02-19

    Dexcom G6 CGM App iOS Software Recall for Low Alarm Defect

    Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.

    Product
    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1149-2020·2020-02-19

    Blue Ortho TKA Pro Software Recalled for Incorrect Navigation Data

    Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.

    Product
    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·20V089000·2020-02-14

    Mercedes-Benz Recalls Vehicles for Instrument Cluster Software Defect

    Mercedes-Benz is recalling specific 2020-2021 models because instrument cluster software may deactivate interior switch illumination, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, CLA 250, GLS450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2020·2020-02-12

    Dexcom G5 Mobile Receiver Recalled for Software Glitches

    Dexcom Inc is recalling 112,415 G5 Mobile Receivers due to software issues that may prevent patients from receiving glucose values or alerts.

    Product
    Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in peo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2020·2020-02-12

    Biomerieux VIDAS 3 Immunoanalyzer Recalled for False Results Due to Software Error

    Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.

    Product
    BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0866-2020·2020-02-05

    RayStation Treatment Planning Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

    Product
    RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2020·2020-02-05

    Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping

    Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.

    Product
    Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide