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.

801–825 of 1335

  • ModerateFDA (Devices)·Z-1116-2017·2017-02-08

    Siemens Syngo.plaza PACS Software Recall for Issue Resolution

    Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.

    Product
    Syngo.plaza, picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1029-2017·2017-01-25

    Fresenius 2008K@home Hemodialysis System Recalled for Software Defect

    Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.

    Product
    Fresenius 2008K@home Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1055-2017·2017-01-25

    Binding Site Digital RID Plate Reader Recalled for Software Defect

    The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.

    Product
    Digital RID Plate Reader and Software Product Code: AD400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1045-2017·2017-01-25

    DICOM GRID Recalls Ambra PACS Software Due to Image Display Error

    DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.

    Product
    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0990-2017·2017-01-18

    Varian Eclipse Treatment Planning System Software Recall for Contouring Errors

    Varian Medical Systems is recalling 42 Eclipse Treatment Planning System devices due to a software defect that prevents contours from saving consistently.

    Product
    Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign d
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0987-2017·2017-01-18

    Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect

    Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.

    Product
    Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·16V950000·2016-12-23

    ARBOC Spirit of Liberty Buses Recalled for Parking Brake Defect

    ARBOC is recalling 2015-2016 Spirit of Liberty transit buses because the parking brake may engage unexpectedly while driving, increasing crash risk.

    Product
    ARBOC — ARBOC SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0768-2017·2016-12-21

    Beckman Coulter Recalls MicroScan LabPro Data Management System Software

    Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

    Product
    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0706-2017·2016-12-14

    Philips Spectral CT Software Recalled for Image Processing Defects

    Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.

    Product
    Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0707-2017·2016-12-14

    Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors

    Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.

    Product
    Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, com
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2017·2016-12-14

    Philips IQon Spectral CT Software Defect Recall

    Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.

    Product
    IQon Spectral CT is a Computed Tomography X-Ray System 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
    7 states
  • ModerateFDA (Devices)·Z-0668-2017·2016-12-07

    Elekta Monaco TRP System Software Recall for CT Data Handling Error

    Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.

    Product
    Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0411-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy System Software Defect Recall

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to a software defect that causes 2D contour projections to appear off from their true position.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diff
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2017·2016-11-23

    Merge PACS software recall due to unviewed image display defect

    Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.

    Product
    SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diffe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2017·2016-11-23

    Siemens Recalls SOMATOM Definition AS CT Systems for Software Update

    Siemens is recalling seven SOMATOM Definition AS CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at differe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2017·2016-11-23

    Merge Healthcare Recalls iConnect Access Software Due to Display Error

    Merge Healthcare is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2 because the software displayed incorrect prior reports when viewing multiple studies.

    Product
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide