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.

1101–1125 of 1335

  • 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 work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • HighFDA (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 usi
    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-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 wi
    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-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
  • 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 of
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1513-2014·2014-05-07

    Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error

    Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.

    Product
    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1469-2014·2014-04-23

    Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect

    Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.

    Product
    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1464-2014·2014-04-23

    Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures

    Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.

    Product
    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2014·2014-04-09

    Elekta Integrity Software Recalled for Incorrect Radiation Beam Delivery Tolerances

    Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.

    Product
    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2014·2014-04-09

    Philips Pinnacle3 Radiation Therapy Planning System Software Recall

    Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.

    Product
    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1307-2014·2014-04-09

    RayStation Radiation Therapy Software Recalled for Potential Dose Errors

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.

    Product
    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1275-2014·2014-04-02

    Velocity Medical Solutions Recalls DICOM Export Format Software

    Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.

    Product
    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2014·2014-04-02

    Spacelabs Recalls G2 Clinical Access Software CDs Due to Incorrect Programs

    Spacelabs Healthcare is voluntarily recalling G2 Clinical Access Software CDs because they contain incorrect programs, preventing customers from installing the software.

    Product
    Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V163000·2014-03-31

    Land Rover Recalls 2014 Range Rovers for Turn Signal Software Defect

    Jaguar Land Rover is recalling 5,238 2014 Range Rovers because a software defect may prevent the turn signal indicator from flashing at a double rate to warn of a malfunction.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2014·2014-03-26

    GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact

    GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.

    Product
    GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2014·2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2014·2014-03-26

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2014·2014-03-19

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Transmission Bug

    Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.

    Product
    Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2014·2014-03-12

    GE Healthcare GSI Viewer Software Recall for Inaccurate Line Measurements

    GE Healthcare is recalling GSI Viewer software because changing the region of interest or zooming may result in inaccurate line measurements.

    Product
    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2014·2014-03-12

    Toshiba CT Systems Recalled for X-Ray Output Software Defect

    Toshiba is recalling 338 Aquilion CT systems because a software defect may prevent X-ray exposure from starting during contrast studies.

    Product
    TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X
    Category
    Medical Device
    Distribution
    Distributed nationwide