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.

26–50 of 276

  • HighFDA (Devices)·Z-0750-2024·2024-01-24

    GammaPod Radiation Treatment Planning System Software Error Allows Wrong Imaging Structures

    Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.

    Product
    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2024·2023-12-20

    Sensica Urine Output System displays incorrect timestamps when connected to WiFi

    The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.

    Product
    Sensica Urine Output System, Catalog Number SCCS1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2024·2023-11-15

    StealthStation S8 Surgical Navigation System Software Anomaly Recall

    Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.

    Product
    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2022·2022-10-05

    Diagnostic imaging software may lose patient information edits during processing

    Ambra PACS and ProViewer versions 3.22.2.0 and 3.22.3.0 have a software defect where patient information edits may be lost during initial study processing due to a race condition between database systems.

    Product
    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1018-2022·2022-05-11

    Medical Device Software Update Overwrites Custom Antibiotic Codes

    BD Synapsys Microbiology Informatics Software version 4.10 overwrites customer-configured antibiotic codes with BD defaults during system updates, affecting data integrity in clinical microbiology reporting.

    Product
    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2021·2021-09-22

    Roche cobas infinity software may release incorrect test results to laboratories

    Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.

    Product
    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2021·2021-09-01

    Laboratory Data Management Software Recalled for Potential Patient Result Errors

    Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.

    Product
    Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2021·2021-08-18

    MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly

    BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.

    Product
    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2021·2021-06-30

    Cardiac assessment system may display test reports in wrong patient records

    GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

    Product
    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2021·2021-06-09

    Elekta MOSAIC Oncology Information System Recalled Due to Malware Attack

    Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.

    Product
    Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2021·2021-05-12

    GE Healthcare Recalls Centricity Universal Viewer for Patient Data Mismatch Risk

    GE Healthcare is recalling 112 units of Centricity Universal Viewer software because a specific configuration may display comparison exams from the wrong patient.

    Product
    Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2021·2021-04-21

    RayStation Software Recall Due to Potential Data Synchronization Errors

    RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.

    Product
    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1162-2021·2021-03-10

    Nihon Kohden Telemetry Recalled for Incorrect Date Stamp or No Data Transfer

    Nihon Kohden America Inc is recalling WMTS Telemetry Receivers because they may display incorrect date stamps or fail to transfer data.

    Product
    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0952-2021·2021-02-10

    Topcon Harmony Referral System Recalled for Patient Data Mixing

    Topcon Medical Systems is recalling 13 Harmony Referral System units because software flaws allowed non-unique patient IDs to merge distinct patient records and images.

    Product
    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0843-2021·2021-01-20

    Medtronic CareLink Diabetes Software Recalled for Data Transfer Errors

    Medtronic is recalling CareLink Personal and System software due to potential RF interference during data uploads, which may cause incomplete basal rate information and inappropriate therapy changes.

    Product
    CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2021·2021-01-20

    Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors

    Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.

    Product
    All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0563-2021·2020-12-16

    Spacelabs Sentinel V10 and V11 Software Upgrade Recall

    Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.

    Product
    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2021·2020-11-04

    Pentax 9310HD Digital Video Capture Module Recalled for Software Error

    Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.

    Product
    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2021·2020-11-04

    Pentax 9372HD Digital Capture Software Recall for Patient Data Error

    Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.

    Product
    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2980-2020·2020-09-23

    Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure

    Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.

    Product
    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2885-2020·2020-09-02

    Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors

    Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.

    Product
    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2496-2020·2020-07-15

    Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error

    Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.

    Product
    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement T
    Category
    Medical Device
    Distribution
    15 states
  • 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