The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 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 106 (8%) 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.

1126–1150 of 1375

  • 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…
    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…
    Category
    Medical Device
    Distribution
    1 state
  • 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
  • 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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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
  • 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…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1665-2014·2014-06-04

    GE Healthcare Recalls Centricity PACS Workstation Due to Image Rejection Error

    GE Healthcare is recalling 297 Centricity PACS Workstations because a software defect may cause images from previously displayed studies to be rejected unintentionally.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2014·2014-06-04

    AGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect

    AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.

    Product
    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1667-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors

    Siemens is recalling 257 ACUSON SC2000 ultrasound systems due to software issues that may cause incorrect color flow data display and Doppler waveform failures.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1567-2014·2014-05-21

    CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue

    CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.

    Product
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1617-2014·2014-05-21

    McKesson Radiology-PACS software recall for missing high-priority alert icon

    McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.

    Product
    McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2014·2014-05-14

    GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect

    GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1549-2014·2014-05-14

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect

    GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1551-2014·2014-05-14

    GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect

    GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.

    Product
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1547-2014·2014-05-14

    GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.

    Product
    Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial…
    Category
    Medical Device
    Distribution
    0 states