The Recall Desk

Hazard

Incorrect Data recalls

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

What the numbers show

Total
50
Critical
0
Severe
0
Most recent
2020-11-04

Of the 50 incorrect data 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 incorrect data 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 50

  • HighFDA (Devices)·Z-2361-2020·2020-06-24

    Abaxis Recalls Piccolo Xpress Chemistry Analyzers Due to Incorrect Reference Ranges

    Abaxis Inc is recalling 15 Piccolo Xpress chemistry analyzers because they display incorrect reference ranges for analytes, which may affect test result interpretation.

    Product
    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1465-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.

    Product
    RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1466-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1149-2020·2020-02-19

    Blue Ortho TKA Pro Software Recalled for Incorrect Navigation Data

    Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.

    Product
    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0303-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2018·2018-02-28

    Medtronic CareLink iPro Software Recall for Time Conversion Error

    Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.

    Product
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2712-2017·2017-07-19

    Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

    Product
    APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2708-2017·2017-07-19

    Toshiba XARIO 100 Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.

    Product
    XARIO 100 TUS-X100 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2017·2017-07-19

    Toshiba APLIO 500 Ultrasound Systems Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.

    Product
    APLIO 500 TUS-A500 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2652-2017·2017-07-05

    AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings

    AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.

    Product
    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2017·2017-04-19

    Merge Hemo software recall for incorrect FFR results display

    Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.

    Product
    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2017·2017-02-15

    Merge RadSuite software recalled due to incorrect pixel value data

    Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.

    Product
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1052-2017·2017-01-25

    Carestream Ultrasound Systems Recalled for Software Measurement Unit Error

    Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.

    Product
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0369-2017·2016-11-16

    Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations

    Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.

    Product
    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2017·2016-10-19

    RaySearch Radiation Therapy Treatment Planning System Software Recall

    RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.

    Product
    Radiation Therapy Treatment Planning System, Model 5.0
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2853-2016·2016-09-28

    Siemens Syngo.via Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2016·2016-08-31

    Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

    Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

    Product
    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
    Category
    Medical Device
    Distribution
    15 states