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.

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.

1076–1100 of 1335

  • ModerateFDA (Devices)·Z-2664-2014·2014-09-24

    Philips CT Systems Recalled for Software Image Overlap Defect

    Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.

    Product
    The Brilliance 64 and Ingenuity CT are 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 equip
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2665-2014·2014-09-24

    Siemens CentraLink Data Management System Software Recall for Timer Overflow

    Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

    Product
    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2574-2014·2014-09-10

    Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch

    Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.

    Product
    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2014·2014-09-10

    Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

    Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

    Product
    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2014·2014-08-20

    Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error

    Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.

    Product
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professiona
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2180-2014·2014-08-20

    Siemens Syngo RT Software Recalled for Sporadic System Crashes

    Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.

    Product
    Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic tre
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treat
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2134-2014·2014-08-06

    Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects

    Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.

    Product
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2121-2014·2014-08-06

    McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy

    McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.

    Product
    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-2075-2014·2014-07-23

    Siemens syngo RT Dosimetrist 2.7 software update addresses data storage issue

    Siemens Medical Solutions is updating syngo RT Dosimetrist 2.7 software to fix a safety issue where structure names were not stored correctly.

    Product
    Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2014·2014-07-23

    Spacelabs Ultraview SL Multigas Module Recalled for Invalid MAC Display

    Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.

    Product
    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2027-2014·2014-07-16

    Hospira MedNet Software Recall for Dosing Unit Transmission Defect

    Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.

    Product
    The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2014·2014-07-16

    United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect

    United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.

    Product
    Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1944-2014·2014-07-09

    Siemens syngo Lab Data Manager Software Recall for Configuration Errors

    Siemens is recalling syngo Lab Data Manager software because configuration errors may cause test results to bypass manual review and release to the Laboratory Information System.

    Product
    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2014·2014-07-09

    Baxter Exactamix Compounder Recall Due to Software Configuration Error

    Baxter Healthcare is recalling Exactamix 1200 and 2400 Compounders because a software error may prevent pump tube flushing, risking cross-contamination of IV solutions.

    Product
    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds mu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2014·2014-07-09

    Nihon Kohden CNS-6201 Central Nurse Station Software Recall

    Nihon Kohden is recalling CNS-6201 Central Nurse Stations with software version 02-26 due to unexpected reboots that interrupt patient data display and alarms.

    Product
    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1869-2014·2014-07-02

    Elekta MOSAIQ Oncology System Recalled for Dose Calculation Error

    Elekta, Inc. is recalling MOSAIQ oncology information system software because it fails to recalculate agent volume when users change the ordering dose.

    Product
    MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2014·2014-06-25

    RayStation Software Recall for Radiation Therapy Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software version 4.0.3.4 due to a bug that causes incorrect dose calculations for radiation therapy plans with variable CT slice spacing.

    Product
    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2014·2014-06-25

    Elekta MOSAIQ software recall for unintended direction selection changes

    Elekta, Inc. is recalling MOSAIQ oncology software versions 1.40 through 2.50 because scrolling actions can unintentionally change direction selections.

    Product
    MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2014·2014-06-25

    Elekta iGUIDE System Recalled Due to Software Logoff Bug

    Elekta, Inc. is recalling 224 iGUIDE Systems because a software bug prevents the system from logging off. The recall covers units distributed worldwide.

    Product
    iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V356000·2014-06-20

    Volvo VNL and VNM Trucks Recalled for Cruise Control Braking Defect

    Volvo is recalling 2011-2015 VNL and 2014-2015 VNM trucks because the active braking component of the enhanced cruise control can become disabled, increasing crash risk.

    Product
    VOLVO — VOLVO VNM, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2014·2014-06-18

    Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop

    Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.

    Product
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2014·2014-06-18

    McKesson Horizon Medical Imaging Software Recalled for Archive Access Issues

    McKesson Medical Imaging is recalling Horizon Medical Imaging software after a complaint that an unreported study could not be opened from the archive.

    Product
    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from va
    Category
    Medical Device
    Distribution
    48 states