The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 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 106 (8%) 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.

626–650 of 1375

  • ModerateFDA (Devices)·Z-1245-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

    Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2019·2019-05-01

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.

    Product
    VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1220-2019·2019-05-01

    Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors

    Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.

    Product
    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1195-2019·2019-04-24

    Siemens syngo Lab Data Manager System Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 449 syngo Lab Data Manager systems due to software issues. The recall covers systems distributed in the US and nine other countries.

    Product
    syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V287000·2019-04-10

    2019 Jeep Renegade and Fiat 500X Recalled for Software Defect

    Chrysler is recalling 2019 Jeep Renegade and Fiat 500X vehicles because incorrect software may disable passive safety features, increasing injury risk in a crash.

    Product
    JEEP — JEEP, FIAT RENEGADE, 500X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2019·2019-04-10

    Advanced Bionics Recalls Three Naída CI Q70 Sound Processors

    Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1083-2019·2019-04-10

    Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

    Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0996-2019·2019-03-20

    Steris Recalls AMSCO 5000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 68 AMSCO 5000 Series Washer/Disinfector units because a software defect may prevent the intended cleaning cycle from processing, potentially leading to inadequate disinfection.

    Product
    AMSCO 5000 Series Washer/Disinfector Model # 5052
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0965-2019·2019-03-06

    Elekta Recalls Monaco Radiation Treatment Planning System Software

    Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning System devices due to a software defect that may cause incorrect optimization models to be used during online plan adaptation.

    Product
    Monaco Radiation Treatment Planning (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0850-2019·2019-02-27

    Baxter Recalls Kaguya Automated Peritoneal Dialysis Systems Due to Software Defect

    Baxter Healthcare is recalling 1,085 Kaguya Automated Peritoneal Dialysis Systems because a software defect may cause shortened dwell times during therapy.

    Product
    Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2019·2019-02-27

    Baxter AMIA Automated Peritoneal Dialysis System Software Recall

    Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.

    Product
    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2019·2019-02-27

    Leica PROVEO 8 Ophthalmic Microscope System Recalled for Software Defects

    Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.

    Product
    PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0823-2019·2019-02-20

    Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues

    Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.

    Product
    Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2019·2019-02-13

    NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error

    Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

    Product
    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2019·2019-02-06

    Siemens Recalls Atellica Sample Handler Prime Due to Software Issues

    Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.

    Product
    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2019·2019-01-30

    Varian Eclipse Treatment Planning System Proton Algorithm Recall

    Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.

    Product
    Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V031000·2019-01-14

    Ford Recalls 2019 Lincoln Nautilus for Lane Center Assist Defect

    Ford is recalling 2019 Lincoln Nautilus vehicles because the Lane Center Assist system may fail to detect if the driver's hands are off the steering wheel for a prolonged period.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states