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.

1251–1275 of 1375

  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2013·2013-09-18

    B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss

    B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2013·2013-09-18

    B. Braun Outlook ES Infusion Pumps Recalled for DoseGuard Software Defect

    B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2013·2013-09-04

    Siemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error

    Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.

    Product
    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2013·2013-08-21

    GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues

    GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.

    Product
    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2013·2013-08-21

    Medtronic Navigation Recalls Framelink Software Version 5.4 for Measurement Discrepancies

    Medtronic Navigation is correcting Framelink software version 5.4 due to potential discrepancies between exam images and displayed measurements during surgical planning.

    Product
    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1944-2013·2013-08-21

    GE Healthcare Recalls LOGIQ S8 Ultrasound Systems for Measurement Errors

    GE Healthcare is recalling 755 LOGIQ S8 Ultrasound Systems due to a software issue that may cause incorrect image measurements in Virtual Convex mode.

    Product
    GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2013·2013-07-31

    Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue

    Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.

    Product
    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2013·2013-07-31

    Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect

    Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.

    Product
    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1732-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

    Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2013·2013-07-03

    Philips CT Scanners Recalled for Patient Selection and Scan Safety Issues

    Philips Medical Systems is recalling 50 CT scanners due to a software defect that can cause incorrect patient names to appear on exam pages and allow clinical scans to start during anti-virus scans.

    Product
    Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2013·2013-06-26

    Respironics V60 Ventilator Recalled for Power Management Board Software Issue

    Respironics is recalling V60 ventilators due to a software issue on the Power Management Board Assembly that could cause loss of ventilator support without an audible alarm.

    Product
    Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2013·2013-06-26

    GE Healthcare Recalls PET VCAR Software Due to Calculation Error

    GE Healthcare is recalling PET VCAR software due to a potential safety issue with automated PERCIST response criteria calculations.

    Product
    GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1560-2013·2013-06-26

    Tecan Freedom EVO Software Recall for Door Lock Safety Defect

    Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.

    Product
    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2013·2013-06-05

    RayStation Therapy Treatment Planning System Recalled for Image Offset Errors

    RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.

    Product
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1402-2013·2013-06-05

    Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues

    Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.

    Product
    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2013·2013-06-05

    Intel-GE Care Innovations Recalls QuietCare-Networked Monitoring Devices

    Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.

    Product
    QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1375-2013·2013-06-05

    Intel-GE QuietCare Recall Issued for Duplicate Alert Functionality

    Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.

    Product
    QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1339-2013·2013-05-29

    Boston Scientific Recalls LATITUDE Patient Management System Software

    Boston Scientific is recalling the LATITUDE Patient Management System software because a system update caused clinic faxes to display illegible characters instead of required patient information.

    Product
    LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2013·2013-05-29

    Technidata TD-Synergy Laboratory Information System Software Recall

    Technidata is recalling TD-Synergy Laboratory Information System software because a specific keyboard shortcut can modify previously entered test results.

    Product
    TD-Synergy. Laboratory Information System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2013·2013-05-08

    Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.

    Product
    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2013·2013-05-01

    GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk

    GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.

    Product
    GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT)…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1163-2013·2013-05-01

    Varian RPM Respiratory Gating System Recall for Waveform Anomaly

    Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.

    Product
    Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2013·2013-04-24

    GE Healthcare Recalls Muse v7 Cardiology System Due to Medication Display Error

    GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.

    Product
    GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd.…
    Category
    Medical Device
    Distribution
    1 state