The Recall Desk

Hazard

Data Integrity recalls

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

What the numbers show

Total
299
Critical
2
Severe
16
Most recent
2026-10-07

Of the 299 data integrity recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (5%) 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 data integrity 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 299

  • SevereFDA (Devices)·Z-3276-2026·2026-10-07

    Volcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error

    Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.

    Product
    Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
    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-3310-2026·2026-10-07

    Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling Ingenia Ambition S and X MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing correct processing by third-party software.

    Product
    Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
    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-3312-2026·2026-10-07

    Philips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data

    Philips North America is recalling 131 MR 5300 systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
    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-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-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-3309-2026·2026-10-07

    Philips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling Ingenia 3.0T MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); 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
  • ModerateFDA (Devices)·Z-3317-2026·2026-10-07

    Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data

    Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.

    Product
    Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3131-2026·2026-09-23

    Nova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect

    Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters due to a software defect that may cause patient data to be assigned to the wrong medical record.

    Product
    StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3128-2026·2026-09-23

    Nova StatStrip Glucose Hospital Meter System Recalled for Software Defect

    Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that may cause patient glucose results to be assigned to the wrong medical record.

    Product
    StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3129-2026·2026-09-23

    Nova Biomedical StatStrip Glucose Hospital Meter System Recalled for Software Defect

    Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that can cause patient glucose results to be assigned to the wrong medical record.

    Product
    StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3132-2026·2026-09-23

    Nova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect

    Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters because a software defect may cause patient data to be assigned to the wrong medical record.

    Product
    StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3130-2026·2026-09-23

    Nova Biomedical StatStrip Glucose Meter Recalled for Data Error

    Nova Biomedical is recalling StatStrip Glucose meters due to a software defect that may assign patient test results to the wrong medical record.

    Product
    StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3170-2026·2026-09-23

    GE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors

    GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2026·2026-09-23

    GE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors

    GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3167-2026·2026-09-23

    GE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors

    GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.

    Product
    Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors

    GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2026·2026-09-23

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors

    GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2913-2026·2026-08-19

    Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies

    Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.

    Product
    navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2876-2026·2026-08-12

    GE Healthcare MAC VU360 Electrocardiograph Software Recall

    GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.

    Product
    GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
    Category
    Medical Device
    Distribution
    Distributed nationwide