The Recall Desk

Hazard

Incorrect Dose Calculation recalls

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

What the numbers show

Total
27
Critical
0
Severe
5
Most recent
2023-07-05

Of the 27 incorrect dose calculation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (19%) 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 dose calculation 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 27

  • HighFDA (Devices)·Z-2039-2023·2023-07-05

    RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

    RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

    Product
    Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0866-2020·2020-02-05

    RayStation Treatment Planning Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

    Product
    RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2020·2019-12-18

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2561-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy plans.

    Product
    Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2019·2019-05-01

    Brainlab RT Elements Software Recalled for Incorrect Dose Calculation

    Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.

    Product
    RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 -
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2554-2018·2018-08-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.

    Product
    RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2018·2018-07-04

    RayStation Radiation Therapy Software Recalled for Dose Calculation Accuracy Issues

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.

    Product
    RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2018·2017-12-13

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a bug in the Bolus Advisor feature may prevent correction bolus advice from being available for recent glucose readings.

    Product
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2017·2016-10-19

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

    Product
    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distri
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2188-2016·2016-07-27

    Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation

    Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.

    Product
    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1719-2016·2016-06-15

    Philips CT System Recalled for Software Defects Affecting Scan Accuracy

    Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-0745-2016·2016-02-10

    Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors

    Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.

    Product
    DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2016·2015-10-14

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.

    Product
    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1712-2015·2015-06-10

    Elekta Oncentra Brachy software recalled for incorrect dose calculation errors

    Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning software because it may calculate incorrect doses for specific regions of interest.

    Product
    Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-1643-2015·2015-05-27

    Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation

    Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.

    Product
    Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2015·2015-03-11

    Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion

    Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.

    Product
    Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1492-2014·2014-04-30

    Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software

    Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.

    Product
    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1197-2014·2014-03-19

    Elekta XiO RPT System Recalled for Incorrect Dose Calculations

    Elekta is recalling the XiO RPT System because dose and monitor unit values are not computed correctly when specific wedges are used with dynamic arcs.

    Product
    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional rad
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1419-2013·2013-06-05

    RayStation Therapy Treatment Planning System Recalled for Image Offset Errors

    RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.

    Product
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    6 states