The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 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 26 (5%) 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.

351–375 of 482

  • HighFDA (Devices)·Z-0716-2016·2016-02-10

    Philips Allura Centron Medical Imaging System Recalled for Image Display Error

    Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as live images during medical procedures.

    Product
    Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2016·2016-02-10

    Philips Recalls Allura Xper FD20 Biplane Systems Due to Image Display Error

    Philips is recalling Allura Xper FD20 Biplane systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2016·2016-02-10

    Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

    Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Display Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2016·2016-02-10

    Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2016·2016-02-10

    Philips Allura Xper FD20/10 Recalled for Image Display Error

    Philips is recalling 13,297 Allura Xper FD20/10 systems because a software error may cause still images to be interpreted as live images.

    Product
    Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2016·2016-01-27

    Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy

    Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.

    Product
    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2016·2016-01-13

    Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

    Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

    Product
    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0581-2016·2016-01-13

    Natus Quantum System Recalled for Reversed Signal Polarity Display

    Natus Medical is recalling 56 Quantum Systems with NeuroWorks 8.1 software because incoming signals display with reversed polarity.

    Product
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with N
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0557-2016·2016-01-06

    Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error

    Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.

    Product
    MOSAIQ Oncology Information System 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 wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2016·2015-12-23

    Philips Ingenuity CT Scanner Software Error Recalled by FDA

    The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2016·2015-12-23

    Philips Brilliance 64 CT System Software Error Recall

    Philips is recalling seven Brilliance 64 CT systems because software may set the scan length differently than planned.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2016·2015-12-02

    NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error

    NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0326-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0336-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0327-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2016·2015-11-18

    GE Healthcare Recalls SIGNA PET/MR 3.0T Scanners for SAR Display Error

    GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2016·2015-11-18

    GE Healthcare Recalls SIGNA Excite 3.0T MR Systems for SAR Display Error

    GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.

    Product
    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0231-2016·2015-11-11

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2785-2015·2015-09-23

    RayStation Radiation Therapy Software Recalled for Display Errors

    RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.

    Product
    Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2015·2015-09-02

    Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error

    Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.

    Product
    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. 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.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2054-2015·2015-07-15

    Siemens Dimension Vista Systems Recalled for Software Processing Errors

    Siemens is recalling Dimension Vista Systems due to software issues that may cause samples to stop processing or deliver incorrect reagents, leading to unexpected test results.

    Product
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2015·2015-06-17

    Ortho-Clinical Diagnostics Recalls VITROS Urine Assay Data Disks

    Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.

    Product
    Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidi
    Category
    Medical Device
    Distribution
    Distributed nationwide