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.

276–300 of 482

  • ModerateFDA (Devices)·Z-1495-2017·2017-03-29

    Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files

    Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.

    Product
    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2017·2017-03-29

    Philips CT Scanner Recall for Incorrect 4D CT Image Phase Annotations

    Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.

    Product
    Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equi
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1493-2017·2017-03-29

    Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error

    Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.

    Product
    Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equ
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1122-2017·2017-02-08

    Mevion S250 Proton Therapy Units Recalled for Data Loss Error

    Mevion Medical Systems is recalling two S250 Proton Radiation Therapy units because a software error can cause Delta corrections to be lost.

    Product
    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2017·2017-02-08

    Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error

    Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.

    Product
    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2017·2017-02-01

    Softbank Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.

    Product
    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2017·2017-02-01

    Softbank II Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.

    Product
    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1026-2017·2017-01-25

    Fresenius 2008T Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008T Series Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2017·2017-01-25

    Fresenius 2008K Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.

    Product
    Fresenius 2008K Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2017·2017-01-25

    Fresenius 2008K2 Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008K2 Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2017·2017-01-25

    Carestream Ultrasound Systems Recalled for Software Measurement Unit Error

    Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.

    Product
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0962-2017·2017-01-18

    Medtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error

    Medtronic is recalling 21,111 MRI-conditional cardiac resynchronization therapy devices because the AdaptivCRT feature may appear enabled when it is not active.

    Product
    Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular t
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0991-2017·2017-01-18

    ConforMIS iTotal PS Knee Implant Recalled for Software Measurement Error

    ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.

    Product
    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0875-2017·2017-01-04

    Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error

    Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.

    Product
    NeuViz 64 Multi-slice CT Scanner Systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0876-2017·2017-01-04

    NeuViz 128 CT Scanner Software Recall for Scan Interruption Errors

    Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0720-2017·2016-12-14

    RayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error

    RaySearch Laboratories is recalling RayStation 5.0 software due to a potential error in dose display on auxiliary CT images, which could result in incorrect treatment planning data.

    Product
    Radiation Therapy Treatment Planning System Product Usage: 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 the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2017·2016-12-14

    Philips Ingenuity CT Systems Recalled for Software Timer Error

    Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and e
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0693-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.

    Product
    Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0696-2017·2016-12-14

    Philips Ingenuity Core 128 MRI Software Recall for Timer Error

    Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.

    Product
    Ingenuity Core 128 728323
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-0695-2017·2016-12-14

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-0694-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.

    Product
    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0673-2017·2016-12-07

    Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results

    Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.

    Product
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq Two Channel Infusers because a white screen error during KVO titration could delay therapy and cause significant injury.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq One Channel Infusers because a white screen during KVO titration may allow premature programming, potentially causing therapy delays and significant injury.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administratio
    Category
    Medical Device
    Distribution
    Distributed nationwide