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.

476–487 of 487

  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2401-2012·2012-09-26

    Zoll X Series Defibrillators Recalled for Incorrect Software

    ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.

    Product
    Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2012·2012-09-12

    Capintec Captus 3000 Thyroid Uptake System Software Error Recall

    Capintec is recalling Captus 3000 Thyroid Uptake Systems with specific software revisions due to a potential error in the 'Measure Liquid and Subtract Residual' protocol.

    Product
    Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2012·2012-08-15

    Radiometer ABL800 Software Recall for HL7 Data Transmission Errors

    Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.

    Product
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2012·2012-08-01

    Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error

    Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.

    Product
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2037-2012·2012-07-25

    Hitachi Scenaria CT System Software Recall for Reconstruction Error

    Hitachi is recalling Scenaria CT System software due to a defect that may cause incomplete image reconstruction, potentially resulting in missing diagnostic data.

    Product
    Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2012·2012-07-25

    Varian Eclipse Treatment Planning System Recall for Radiotherapy Prescription Errors

    Varian is recalling Eclipse Treatment Planning Systems because changing dose prescriptions in certain plans may result in incorrect Monitor Units and dose distributions.

    Product
    Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2030-2012·2012-07-25

    Sigma Recalls Infusion Pump Master Drug Library Editor Software

    Sigma issued a safety alert for the SIGMASpectrum Infusion Pump Master Drug Library Editor software because it may create drug libraries that do not reflect common clinical practices.

    Product
    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2012·2012-07-18

    Impac Medical MOSAIQ Oncology System Recall for Wedge Motor Unit Error

    Impac Medical is recalling MOSAIQ Oncology Information Systems due to a software error that incorrectly resets remaining Wedge Motor Units to zero after a machine fault.

    Product
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
    Category
    Medical Device
    Distribution
    5 states
  • ModerateNHTSA·10V335000·2010-07-22

    Volvo Recalls S80 Vehicles for Incorrect Tire Pressure Information

    Volvo is recalling 2007-2010 S80 vehicles because tire labels and monitoring software contain incorrect pressure data, failing federal safety standards.

    Product
    VOLVO — VOLVO S80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·03079·2003-02-05

    UWATEC Recalls 1995 Aladin Air X NitrOx Dive Computers

    UWATEC is recalling 1995 Aladin Air X NitrOx dive computers because software errors may cause decompression sickness. Consumers should stop using them and contact UWATEC for a free replacement.

    Product
    Aladin Air X NitrOx dive domputers
    Category
    Consumer Product
    Distribution
    Distributed nationwide