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.

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 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.

726–750 of 1335

  • HighFDA (Devices)·Z-0235-2018·2017-12-20

    Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results

    Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.

    Product
    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provid
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·17V814000·2017-12-18

    Ford Recalls 2018 Mustangs for Instrument Cluster Software Defect

    Ford is recalling 2018 Mustangs with automatic transmissions because the instrument cluster may fail to display the gear position or provide an audible warning when the ignition is off, increasing the risk of the vehicle rolling away.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V804000·2017-12-14

    2017 Mercedes-Benz and Freightliner Sprinter 3500 Recall for Crosswind Assist Defect

    Daimler Vans USA is recalling 2017 Mercedes-Benz and Freightliner Sprinter 3500 vehicles because the Crosswind Assist system may fail to activate automatic braking in strong crosswinds, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2018·2017-12-13

    ICU Medical Recalls MedNet Medication Management Suite Software

    ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.

    Product
    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to faci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2018·2017-12-06

    Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error

    Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.

    Product
    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Rad
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0189-2018·2017-12-06

    Volcano Imaging Systems Recalled Due to Unexpected Windows Security Dialog

    Volcano Corporation is recalling specific intravascular ultrasound imaging systems because an unexpected Microsoft Windows Security dialog may appear during use, potentially affecting device operation.

    Product
    Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Error

    Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.

    Product
    ROSA Surgical Device 2.5.8
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0168-2018·2017-11-29

    Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy

    Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.

    Product
    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the ph
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0161-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Software

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.

    Product
    ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2018·2017-11-22

    Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

    Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagen
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0094-2018·2017-11-22

    Siemens Symbia Intevo 6 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 6 SPECT/CT systems because a software option may prevent users from modifying specific data input values during calibration.

    Product
    Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0093-2018·2017-11-22

    Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.

    Product
    Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPEC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0049-2018·2017-11-01

    FDA Requests Removal of Ablatherm Ultrasound System Software Settings

    FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.

    Product
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0050-2018·2017-11-01

    Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size

    Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.

    Product
    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2018·2017-10-25

    Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
  • ModerateFDA (Devices)·Z-0019-2018·2017-10-25

    Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure

    Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
  • ModerateFDA (Devices)·Z-0017-2018·2017-10-25

    Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure

    Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
  • ModerateFDA (Devices)·Z-0015-2018·2017-10-25

    Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure

    Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.

    Product
    Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
  • ModerateFDA (Devices)·Z-0018-2018·2017-10-25

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are 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
  • ModerateFDA (Devices)·Z-0016-2018·2017-10-25

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.

    Product
    Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are 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-3130-2017·2017-09-20

    Mako Surgical Recalls Robotic Knee System Due to Software Display Error

    Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.

    Product
    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3110-2017·2017-09-13

    Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error

    Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.

    Product
    MOSAIQ Medical Charged-Particle Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2017·2017-09-13

    Merge Unity Software Recall for Incorrect Gail Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2017·2017-09-13

    Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.

    Product
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3045-2017·2017-09-06

    Neusoft NeuViz 128 CT Scanner Software Defect Recall

    Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.

    Product
    Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The 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 transmission data is reconstruc
    Category
    Medical Device
    Distribution
    Distributed nationwide