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.

926–950 of 1335

  • ModerateFDA (Devices)·Z-1075-2016·2016-03-16

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

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry Sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0862-2016·2016-03-02

    Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues

    Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.

    Product
    Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology informat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2016·2016-03-02

    Olympus Delta XRF Analyzer Recalled Due to Software Bug

    Olympus Scientific Solutions Americas is recalling Delta XRF Analyzers because the firm discovered a software bug.

    Product
    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V113000·2016-02-26

    Chrysler Recalls 2015-2016 Dodge Dart Vehicles for Software Defect

    Chrysler is recalling certain 2015 and 2016 Dodge Dart vehicles because a missing software backup in the powertrain control module may increase the risk of a crash.

    Product
    DODGE — DODGE DART
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2016·2016-02-10

    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 V5000: Model Number: 72248 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-0702-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error

    Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.

    Product
    Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2016·2016-02-10

    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 BN/BV3000; Model Number: 72240 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 interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

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

    Product
    INTEGRIS CV; Model Number: 722030 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 pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2016·2016-02-10

    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 misinterpreted as live images.

    Product
    INTEGRIS BV5000: Model Number: 72249 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-0703-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Display Error

    Philips is recalling Allura Xper FD10/10 systems because a software issue may cause still images to be mistaken for live images during X-ray procedures.

    Product
    Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2016·2016-02-10

    Philips UNIQ and Allura Systems Recall for Image Interpretation Error

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

    Product
    UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2016·2016-02-10

    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 misinterpreted as live images.

    Product
    INTEGRIS BH3000; Model Number: 72242 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-0708-2016·2016-02-10

    Philips UNIQ and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk

    Philips is recalling INTEGRIS and Allura medical imaging systems because software issues may cause still images to be misinterpreted as live images during procedures.

    Product
    INTEGRIS H5000; Model Number: 72246 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
  • ModerateFDA (Devices)·Z-0755-2016·2016-02-10

    Siemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues

    Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.

    Product
    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (IS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2016·2016-01-20

    Brainlab RT Elements software recall for image cropping defect

    Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2016·2016-01-20

    Brainlab Brain Metastases Software Recall for Image Display Errors

    Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2016·2016-01-13

    Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error

    Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.

    Product
    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0554-2016·2016-01-06

    Merge Hemo Software Recalled Due to Incomplete Validation

    Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.

    Product
    Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0545-2016·2015-12-30

    Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

    Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2016·2015-12-30

    Philips CT System Recall for Missing Perfusion Scan Feature

    Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2016·2015-12-30

    Philips Ingenuity CT System Recall for Perfusion Software Access Issue

    Philips is recalling 31 Ingenuity CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2016·2015-12-30

    Philips Ingenuity Core CT System Recalled for Perfusion Software Access Issue

    Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.

    Product
    Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2016·2015-12-30

    Philips Brilliance iCT SP CT System Software Feature Recall

    Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT SP Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0544-2016·2015-12-30

    Philips Brilliance 64 CT System Recalled for Perfusion Software Issue

    Philips is recalling 30 Brilliance 64 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide