The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (5%) are Severe.

Which agencies issued them

About this hazard tag

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

401–425 of 482

  • ModerateFDA (Devices)·Z-0176-2015·2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2015·2014-10-15

    McKesson Cardiology Hemo Software Recall for Hemoglobin Calculation Error

    McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices because a software error incorrectly converts hemoglobin values used in formula calculations.

    Product
    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2680-2014·2014-10-01

    Siemens Ysio Systems Recalled for Potential Image Artifacts

    Siemens is recalling 62 Ysio Systems due to a software error that may cause line artifacts in images, potentially requiring examinations to be repeated.

    Product
    The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2644-2014·2014-09-24

    BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72

    BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.

    Product
    JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The sof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2263-2014·2014-08-27

    Biolase Recalls WaterLase iPlus Dental Laser Systems Due to Software Error

    Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.

    Product
    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2267-2014·2014-08-27

    Intelerad IntelePACS Software Recall Due to Potential File Truncation Errors

    Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.

    Product
    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2237-2014·2014-08-20

    Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error

    Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.

    Product
    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterpr
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2141-2014·2014-08-13

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2014·2014-07-23

    Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors

    Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.

    Product
    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1847-2014·2014-07-02

    Baxter Abacus 3.1 Pharmacy Calculator Software Field Correction

    Baxter is correcting a software error in Abacus 3.1 that may display protein levels 1,000 times lower than actual when using Clinimix 4.25110.

    Product
    Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2014·2014-06-11

    Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors

    Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.

    Product
    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2014·2014-05-21

    Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error

    Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.

    Product
    Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2014·2014-04-02

    Bio-Rad D-10 Hemoglobin Testing System Software Recall

    Bio-Rad is recalling D-10 Hemoglobin Testing Systems because the software may occasionally generate duplicate results with incorrect sample identifiers.

    Product
    D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2014·2014-03-19

    Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error

    Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.

    Product
    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2014·2014-03-12

    Elekta Agility Software Recall for Calibration Input Errors

    Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.

    Product
    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2014·2014-03-12

    Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors

    Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.

    Product
    Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2014·2014-03-12

    Elekta Integrity Software Recalled for Calibration Input Errors

    Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.

    Product
    Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2014·2014-03-12

    Elekta Agility software recall for potential calibration input errors

    Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.

    Product
    Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2014·2014-02-26

    Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error

    Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.

    Product
    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Mixing Cup Arrays

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Mixing Cup Arrays used on VITROS 250 and 350 systems due to an increase in software errors.

    Product
    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0965-2014·2014-02-19

    Bio-Rad D-10 Hemoglobin Testing System Software Recall

    Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.

    Product
    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0840-2014·2014-02-05

    GE Optima CT Systems Recalled for Manual Film Composer Data Mismatch

    GE Healthcare is recalling 272 Optima CT520 and CT540 systems because the Manual Film Composer feature may display or print images with incorrect patient names or mismatched image previews.

    Product
    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2014·2014-01-29

    Sorin Orchestra Programmer Overestimates Pacemaker Battery Life

    Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.

    Product
    ORCHESTRA/ORCHESTRA PLUS Programmer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2014·2014-01-15

    Puritan Bennett 840 Ventilator Software Recall for Diagnostic Code XB0069

    Covidien is recalling Puritan Bennett 840 ventilators with specific software revisions because a software error causes the device to stop mechanical ventilation.

    Product
    Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide