The Recall Desk

Hazard

Data Integrity recalls

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

What the numbers show

Total
276
Critical
0
Severe
9
Most recent
2026-08-19

Of the 276 data integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (3%) 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.

51–75 of 276

  • ModerateFDA (Devices)·Z-2484-2020·2020-07-08

    Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2020·2020-07-01

    RayStation Software Recalled for Treatment Record Import and Display Issues

    RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.

    Product
    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0914-2020·2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis pro
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0913-2020·2020-02-05

    Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.

    Product
    iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0877-2020·2020-02-05

    GE Healthcare Recalls MRI Systems Due to Potential Date Setting Error

    GE Healthcare is recalling 62 MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2020·2020-02-05

    GE Healthcare Recalls SIGNA Premier MRI Systems Due to Date Errors

    GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2020·2019-12-25

    GE Healthcare Recalls Aestiva MRI Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0115-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7900 Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling 7,168 Aestiva 7900 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7100 Anesthesia Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 473 Aestiva 7100 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12. 1
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0260-2020·2019-11-06

    Dario Blood Glucose Monitoring System App Recall for Duplicate Logging

    Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.

    Product
    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2020·2019-10-30

    Brainlab Patient Data Manager Software Recall for Data Export Errors

    Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.

    Product
    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2020·2019-10-30

    Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2019·2019-09-04

    Agilent MassHunter Software Recall Due to Sample Data Mismatch

    Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.

    Product
    MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2019·2019-08-14

    Philips Ultrasound Systems Recalled for Patient Data Entry Error

    Philips is recalling EPIQ and Affiniti ultrasound systems with software version 4.0 because patient images may be moved to the wrong folder.

    Product
    Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2019·2019-07-31

    Spacelabs Smart Disclosure System Recalled for Patient Data Mismatch

    Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.

    Product
    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2019·2019-07-31

    GE Healthcare Recalls MAC VU360 Electrocardiographs Due to Patient ID Errors

    GE Healthcare is recalling 369 MAC VU360 electrocardiographs because they may display incorrect patient IDs or demographics, potentially assigning ECG reports to the wrong patient.

    Product
    MAC VU360, Model Number 2030360-001, Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1906-2019·2019-07-10

    Bio-Rad Recalls EVOLIS Microplate System Due to Software Error

    Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.

    Product
    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2019·2019-06-26

    Arkray AUTION HYBRID AU-4050 Recalled for Software Error

    Arkray Factory USA, Inc. is recalling 159 AUTION HYBRID AU-4050 units due to a software issue that could assign incorrect patient information to sample results.

    Product
    AUTION HYBRID AU-4050
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1771-2019·2019-06-19

    Philips Patient Information Center iX Recall for Infusion Pump Data Accuracy

    Philips is recalling Patient Information Center iX software because infusion pump data may be recorded at 100 times the actual rate.

    Product
    Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2019·2019-06-05

    Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect

    Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.

    Product
    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1207-2019·2019-05-01

    Carestream OnSight 3D Extremity System Recalled for Software Data Error

    Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.

    Product
    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2019·2019-04-24

    Topcon IMAGEnet 6 Software Recalled for Patient Data Display Error

    Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.

    Product
    IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functi
    Category
    Medical Device
    Distribution
    Distributed nationwide