The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
487
Critical
2
Severe
30
Most recent
2026-10-14

Of the 487 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 30 (6%) 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.

301–325 of 487

  • 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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2017·2016-10-19

    RaySearch Radiation Therapy Treatment Planning System Software Recall

    RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.

    Product
    Radiation Therapy Treatment Planning System, Model 5.0
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0047-2017·2016-10-12

    Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0048-2017·2016-10-12

    Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2898-2016·2016-10-05

    Medtronic Recalls CareLink iPro Software Due to Time Stamp Error

    Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.

    Product
    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2016·2016-09-28

    Siemens Syngo.x Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2853-2016·2016-09-28

    Siemens Syngo.via Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2016·2016-08-31

    Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

    Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

    Product
    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2625-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling two CT scanners where a software error prevents contrast agent injection during automatic scans, resulting in failed examinations.

    Product
    SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2626-2016·2016-08-31

    Siemens SOMATOM Definition Edge CT Systems Recalled for Injector Failure

    Siemens is recalling four CT systems because a software error prevents the contrast agent injector from starting in automatic or coupled modes.

    Product
    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2624-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.

    Product
    SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2344-2016·2016-08-17

    Siemens Artis Angiography Systems Recalled for Image Reproduction Failure

    Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.

    Product
    Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2016·2016-08-10

    BK Medical bk3500 Ultrasound Scanner Recalled for Volume Calculation Error

    B-K Medical A/S is recalling six bk3500 ultrasound systems because the generic volume measurement function may display incorrect calculations, potentially affecting diagnostic accuracy.

    Product
    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2188-2016·2016-07-27

    Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation

    Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.

    Product
    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-2143-2016·2016-07-20

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.

    Product
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2016·2016-07-06

    Siemens Syngo.plaza PACS Software Recall for Database Error

    Siemens is recalling 74 Syngo.plaza PACS systems due to a software error that may create duplicate image references in the database.

    Product
    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-1948-2016·2016-06-22

    Leica Biosystems Recalls Ariol Automated Scanning Microscopes Due to Software Issue

    Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope systems because a manufacturing error resulted in an improperly activated Windows 7 operating system.

    Product
    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1872-2016·2016-06-08

    Philips Brilliance 64 CT Systems Recalled for Software Mapping Error

    Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.

    Product
    Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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-1593-2016·2016-05-11

    Carestream Image Suite V3 Recalled for Incorrect Image Annotation

    Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

    Product
    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream…
    Category
    Medical Device
    Distribution
    Distributed nationwide