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.

1–25 of 1375

  • ModerateFDA (Devices)·Z-0186-2027·2026-10-21

    Intelerad IntelePACS Software Recalled for Image Display Mismatch

    Intelerad Medical Systems is recalling IntelePACS software versions because reported and displayed images may not match due to a web-browser issue.

    Product
    IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2027·2026-10-14

    Philips Spectral CT Systems Recalled for Software Issues Affecting Safety

    Philips Medical Systems is recalling 539 Spectral CT systems due to software issues that may cause image artifacts, wrong slice thickness, or unintended system motion.

    Product
    Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0083-2027·2026-10-14

    Beckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error

    Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules because a software issue can cause test units to revert to defaults without warning, potentially resulting in falsely elevated reported results.

    Product
    DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2027·2026-10-14

    Steris HexaVue Focus Integration System Recalled for Patient Data Mismatch

    Steris is recalling 58 HexaVue Focus Integration Systems because a software issue may cause incorrect patient information to appear on printed images.

    Product
    HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2026·2026-10-07

    United Imaging uCT 530 CT Systems Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 530 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3330-2026·2026-10-07

    Tandem t:slim iOS App Recall Due to CGM Pairing Failure

    Tandem Diabetes Care is recalling a beta version of its t:slim iOS app because it fails to pair with Abbott FreeStyle Libre 3 Plus sensors, forcing users into manual mode.

    Product
    Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3281-2026·2026-10-07

    United Imaging uCT ATLAS CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling 11 uCT ATLAS CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT ATLAS with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3287-2026·2026-10-07

    United Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling six uMI Panvivo S PET/CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3278-2026·2026-10-07

    United Imaging uCT 550 CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling 23 uCT 550 CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 550 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3307-2026·2026-10-07

    Philips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors

    Philips is recalling six Ingenia Blue Seal MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3284-2026·2026-10-07

    United Imaging uMI Panorama 35 PET/CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling seven uMI Panorama 35 PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3280-2026·2026-10-07

    United Imaging uCT 780 CT System Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling 14 uCT 780 CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 780 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3279-2026·2026-10-07

    United Imaging uCT 760 CT System Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling one uCT 760 CT system due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 760 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3282-2026·2026-10-07

    United Imaging CT System Recall Due to Software Image Visibility Issue

    Shanghai United Imaging Healthcare is recalling 53 uCT ATLAS Astound CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3316-2026·2026-10-07

    Philips Upgrade dStream Software Recall for Incorrect DTI Data Exports

    Philips is recalling Upgrade dStream software versions R11-R13 because DTI scan exports contain incorrect diffusion direction data, preventing correct tractography reconstruction.

    Product
    Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3315-2026·2026-10-07

    Philips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data

    Philips is recalling five SmartPath to MR 7700 units because diffusion tensor imaging exports contain incorrect data, preventing correct processing by third-party software.

    Product
    SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3288-2026·2026-10-07

    United Imaging uMI 780 PET/CT System Software Recall

    Shanghai United Imaging Healthcare is recalling one uMI 780 PET/CT system due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 780
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3285-2026·2026-10-07

    United Imaging uMI Panorama GS PET/CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling three uMI Panorama GS PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3314-2026·2026-10-07

    Philips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data

    Philips is recalling SmartPath MRI software because it exports incorrect diffusion tensor imaging data, preventing correct processing by third-party tractography software.

    Product
    SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3311-2026·2026-10-07

    Philips Recalls Ingenia MRI Systems Due to Incorrect DTI Export Data

    Philips is recalling 340 Ingenia MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate third-party processing.

    Product
    Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3286-2026·2026-10-07

    United Imaging uMI Panvivo PET/CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling three uMI Panvivo PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3308-2026·2026-10-07

    Philips Ingenia MRI Systems Recalled for Incorrect DTI Export Data

    Philips is recalling Ingenia 1.5T MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate processing by third-party software.

    Product
    Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3283-2026·2026-10-07

    United Imaging uMI 550 PET/CT Systems Recalled for Software Defect

    FDA is recalling 34 United Imaging uMI 550 PET/CT systems due to a software issue that can hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3318-2026·2026-10-07

    Philips MRI Systems Recalled for Incorrect Diffusion Tensor Imaging Data Exports

    Philips is recalling 91 Evolution MRI systems because Enhanced MR DICOM exports contain incorrect diffusion directions, preventing correct tractography reconstruction.

    Product
    Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3313-2026·2026-10-07

    Philips MR 7700 MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling 107 MR 7700 MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide