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.

251–275 of 482

  • ModerateFDA (Devices)·Z-0661-2018·2018-02-28

    Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

    Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

    Product
    ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is in
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0660-2018·2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0670-2018·2018-02-28

    Medtronic CareLink iPro Software Recall for Time Conversion Error

    Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.

    Product
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0659-2018·2018-02-28

    Fujifilm Aspire HD Mammography System Recalled for Image ID Error

    Fujifilm is recalling Aspire HD mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0409-2018·2018-01-31

    Smith & Nephew Taylor Spatial Frame Software Recalled for Image Inversion

    Smith & Nephew is recalling Taylor Spatial Frame software versions 5.2.5 and 5.2.6 because the software may generate inverted images of the frame during strut adjustment planning.

    Product
    Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengtheni
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0184-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0167-2018·2017-11-29

    Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors

    Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.

    Product
    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift

    Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.

    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
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0046-2018·2017-11-01

    Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error

    Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.

    Product
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3131-2017·2017-09-20

    Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software

    Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.

    Product
    Total Hip Application (THA) 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 procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3111-2017·2017-09-20

    Toshiba Medical Radrex-i Digital Radiography X-ray System Recalled for Software Error

    Toshiba American Medical Systems is recalling 140 Radrex-i digital radiography systems because a software error causes image loss and requires a system reboot.

    Product
    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3050-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 367 ORA Systems with VerifEye because a software error may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2688-2017·2017-07-12

    Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation

    Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.

    Product
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2672-2017·2017-07-12

    Ion Beam Applications Recalls Proteus Proton Therapy Systems for Software Issues

    Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.

    Product
    Proteus 235 and Proteus ONE proton therapy systems
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2109-2017·2017-06-07

    Toshiba Angio WorkStation Recalled for Dose Tracking Display Error

    Toshiba is recalling 70 Angio WorkStation units because the Peak Skin Dose value may display incorrectly if the workstation is powered on after the Infinix system.

    Product
    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2076-2017·2017-05-24

    Zimmer CAS Recalls Navitrack System OS Knee Universal Software

    Zimmer CAS is voluntarily recalling Navitrack System OS Knee Universal software versions due to software issues causing errors and discrepancies.

    Product
    Navitrack System - OS Knee Universal, Stereotaxic instrument
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2040-2017·2017-05-17

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Patient ID Error

    Siemens is recalling 159 RAPIDPoint 500 Blood Gas Analyzers because a blank patient ID field may cause demographic errors.

    Product
    RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2017·2017-04-19

    RayStation Radiation Therapy Software Recalled for GPU Driver Error

    RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.

    Product
    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2017·2017-04-19

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

    Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

    Product
    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2017·2017-04-12

    Philips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error

    Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems because electronic markers may be placed at the wrong anatomical position when images are moved between views.

    Product
    Mobile Diagnostic X-Ray System with Digital Panel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1694-2017·2017-04-05

    Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

    Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

    Product
    SynchroMed II implantable drug infusion pump, Model 8637-40,
    Category
    Medical Device
    Distribution
    1 state