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.

1201–1225 of 1335

  • HighFDA (Devices)·Z-0168-2014·2013-11-13

    Roche COBAS INTEGRA 800 Analyzer Recalled for Software Maintenance Defect

    Roche Diagnostics is recalling 527 COBAS INTEGRA 800 Analyzers with software version 9864.C2 because the system fails to perform necessary ISE service actions and maintenance requests.

    Product
    COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2014·2013-11-13

    Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall

    Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.

    Product
    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2014·2013-11-13

    Carestream DRX Mobile X-Ray Systems Recalled for Software Defect

    Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.

    Product
    CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2014·2013-11-06

    Philips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk

    Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.

    Product
    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2014·2013-11-06

    GE Centricity PACS Workstation Recalled for Workflow Interruption Issues

    GE Healthcare is recalling 623 Centricity PACS Workstations due to software workflow interruptions that may prevent exams from closing correctly in the system.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0052-2014·2013-10-30

    Siemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images

    Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.

    Product
    Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0032-2014·2013-10-30

    Bio-Rad Recalls FSE Image Upgrade Kits Due to Data Export Issues

    Bio-Rad Laboratories is recalling 23 FSE Image Upgrade Kits because of a software issue that affects data export from the EVOLIS analyzer to Laboratory Information Systems.

    Product
    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2301-2013·2013-10-09

    Hologic Selenia Mammography System Software Recall for Image Deletion

    Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.

    Product
    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2276-2013·2013-10-02

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.

    Product
    Monaco RTP System Radiation treatment planning
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2013·2013-09-25

    GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk

    GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 co
    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 con
    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 dete
    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
  • 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 (Volumetric),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 Vasc
    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 iden
    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-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-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 temperatur
    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) 1076
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 for
    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