The Recall Desk

Hazard

Data Mismatch recalls

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

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2023-10-25

Of the 17 data mismatch recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 mismatch 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.

1–17 of 17

  • HighFDA (Devices)·Z-0122-2024·2023-10-25

    Functional MRI Software Bug May Cause DICOM Export Data Mismatch

    A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

    Product
    Functional MR V1.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2093-2021·2021-07-28

    Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results

    SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.

    Product
    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and tra
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2297-2020·2020-06-17

    Elekta Unity Software Recall for Motion Monitoring Data Mismatch

    Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.

    Product
    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems worldwide because software issues may cause flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2018·2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2018·2018-02-07

    Roche Elecsys 2010 Analyzer Software Malfunction Recall

    Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.

    Product
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2016·2016-09-21

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because patient names may be printed with results from a different patient.

    Product
    Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2016·2016-09-21

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Patient Data Mismatch

    Siemens is recalling 492 RAPIDPoint 400 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2803-2016·2016-09-21

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDLab 1265 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2016·2016-02-24

    CareFusion Recalls Jadak Barcode Scanners for Pyxis Anesthesia Systems

    CareFusion 303, Inc. is recalling 9,345 Jadak Barcode Scanners used with Pyxis Anesthesia systems because they may transmit incorrect medication information to the dispensing system.

    Product
    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0947-2015·2015-01-21

    Phadia 1000 Instrument Recalled for Rack Sequencing Error

    Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.

    Product
    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utili
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2014·2014-08-13

    PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk

    PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.

    Product
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0840-2014·2014-02-05

    GE Optima CT Systems Recalled for Manual Film Composer Data Mismatch

    GE Healthcare is recalling 272 Optima CT520 and CT540 systems because the Manual Film Composer feature may display or print images with incorrect patient names or mismatched image previews.

    Product
    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2013·2013-08-21

    GE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk

    GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.

    Product
    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVAT
    Category
    Medical Device
    Distribution
    Distributed nationwide