The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
487
Critical
2
Severe
30
Most recent
2026-10-14

Of the 487 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software error 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.

176–200 of 487

  • HighFDA (Devices)·Z-2164-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.

    Product
    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2202-2020·2020-06-10

    Agfa DR 800 X-Ray System Recalled for Dose Calculation Error

    Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V285000·2020-05-20

    Navistar Recalls 2019-2020 International CV Vehicles Due to ABS Software Error

    Navistar is recalling 2019-2020 International CV vehicles because a software error may prevent the ABS warning light from illuminating, potentially leaving drivers unaware of system failures.

    Product
    INTERNATIONAL — INTERNATIONAL CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1725-2020·2020-04-22

    Canon Aquilion Precision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Precision, Model TSX-304A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1722-2020·2020-04-22

    Canon Aquilion One Vision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion One Vision, Model TSX-301C
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1631-2020·2020-04-08

    Ra Medical Systems Recalls Pharos Excimer Laser Due to Software Error

    Ra Medical Systems is recalling 10 Pharos EX-308 Excimer Laser units because a software error may prevent the device from stopping, potentially causing skin burns.

    Product
    Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1552-2020·2020-04-01

    Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error

    Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.

    Product
    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1468-2020·2020-03-18

    RayStation 9B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.

    Product
    RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1467-2020·2020-03-18

    RayStation 9A Software Recall for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • 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-1464-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.

    Product
    RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1361-2020·2020-03-11

    CareFusion Alaris Syringe Module Software Error Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Syringe Module, Model 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1362-2020·2020-03-11

    CareFusion Alaris PCA Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris PCA Module, Model 8120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1360-2020·2020-03-11

    CareFusion Alaris Pump Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Pump Module, Model 8100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1435-2020·2020-03-11

    Siemens Atellica IM Humidity Pack Recall Due to Software Error

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs because a software error causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2020·2020-03-11

    Siemens Atellica IM Humidity Pack Software Error Recall

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs due to a software error that causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2020·2020-03-04

    Randox RX Daytona Plus Clinical Chemistry Analyzer Software Recall

    Randox Laboratories is recalling RX Daytona Plus clinical chemistry analyzers to fix software issues causing incorrect sample ordering and quality control flags.

    Product
    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2020·2020-02-26

    Philips CombiDiagnost PCF X-ray System Software Recall

    Philips is recalling 131 CombiDiagnost PCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2020·2020-02-19

    Roche Recalls cobas infinity core Software Due to Display Error

    Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.

    Product
    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0864-2020·2020-02-05

    Radiometer AQURE basic system software recall for patient data mix-up risk

    Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.

    Product
    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0862-2020·2020-02-05

    Siemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error

    Siemens is recalling 1,528 Atellica CH 930 Analyzers in 17 foreign countries because a barcode scanning error causes the system to use default values instead of specific fluid concentrations for Sodium, Potassium, and Chloride tests.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
    Category
    Medical Device
    Distribution
    0 states