The Recall Desk

Hazard

Software Bug recalls

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

What the numbers show

Total
51
Critical
0
Severe
4
Most recent
2026-08-12

Of the 51 software bug recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (8%) 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 software bug 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 51

  • ModerateFDA (Devices)·Z-0686-2020·2019-12-25

    CVS Health At Home A1C Test Kit Recalled for Software Bug

    Polymer Technology Systems is recalling CVS Health At Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0685-2020·2019-12-25

    ReliOn FastA1C Test Recalled for Software Bug Affecting Result Display

    Polymer Technology Systems is recalling ReliOn FastA1C Tests due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0683-2020·2019-12-25

    Polymer Technology Systems Recalls A1CNow SELF CHECK Software Bug

    Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0583-2020·2019-12-04

    GN Hearing Recalls Behind-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2020·2019-12-04

    GN Hearing Recalls In-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 285 in-the-ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug

    Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.

    Product
    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error

    Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error

    Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.

    Product
    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2018·2018-06-13

    NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

    NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

    Product
    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2018·2018-02-21

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

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a software bug may cause incorrect unit changes, risking inaccurate blood glucose data or carbohydrate input.

    Product
    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
    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
  • ModerateFDA (Devices)·Z-0177-2018·2017-12-06

    Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs

    Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.

    Product
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2017·2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2017·2016-12-14

    Siemens Recalls SOMATOM Force CT Systems for Software Bugs

    Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

    Product
    SOMATOM Force, System x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2017·2016-11-23

    Roche Recalls Accu-Chek Connect iOS App Version 1.2.0 Due to Software Bug

    Roche Diabetes Care is recalling version 1.2.0 of the Accu-Chek Connect iOS app because a programming error in the Bolus Advisor feature could lead to incorrect insulin bolus recommendations.

    Product
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1712-2016·2016-06-01

    RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug

    RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.

    Product
    RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1521-2016·2016-04-27

    Siemens CT Systems Recalled for Software Bugs Causing Scan Aborts

    Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental x-radiation.

    Product
    Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2016·2015-10-14

    Siemens SOMATOM Force CT Systems Recalled for Software and Firmware Bugs

    Siemens Medical Solutions USA is recalling 21 SOMATOM Force computed tomography systems due to software and firmware bugs.

    Product
    SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2016·2015-10-14

    Siemens SOMATOM Definition Edge CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2016·2015-10-14

    Siemens SOMATOM Definition Flash CT Scanner Software Recall

    Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.

    Product
    SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2015·2015-04-29

    Thermedx Fluid Management System P4000 Recalled for Software Bugs

    Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.

    Product
    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1407-2013·2013-06-05

    Alpine Biomed Recalls Natus Dantec KEYPOINT.NET Software Due to Bug

    Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.

    Product
    Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide