The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 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 26 (5%) 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.

126–150 of 482

  • HighFDA (Devices)·Z-2398-2021·2021-09-08

    Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error

    DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2397-2021·2021-09-08

    TruMatch Surgical Instruments Recalled for Software Alignment Error

    DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.

    Product
    TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2396-2021·2021-09-08

    Surgical alignment software error recalled in patient-specific orthopedic instruments

    DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.

    Product
    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2404-2021·2021-09-08

    Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment

    Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.

    Product
    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2395-2021·2021-09-08

    Surgical instrument software error may cause limb misalignment

    DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2387-2021·2021-09-08

    Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue

    Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.

    Product
    Merge Hemo, Software packages 10.2, 10.3, and 10.4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2316-2021·2021-08-25

    CT system software error recommends excessive contrast volume

    A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.

    Product
    728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2021·2021-08-25

    IQon Spectral CT System Software Error Increases Contrast Volume

    Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.

    Product
    728332 IQon Spectral CT-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2021·2021-07-14

    ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results

    Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.

    Product
    The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2021·2021-07-07

    Tempus Pro Patient Monitor Software Error Risk When Unplugged

    Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.

    Product
    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2021·2021-06-23

    Cardiac Monitoring System Software Error May Disable Device

    Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2021·2021-06-23

    WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss

    WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.

    Product
    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21748·2021-05-20

    John Deere Recalls Gator Utility Vehicles Due to Crash Hazard

    John Deere is recalling about 90 Gator utility vehicles because a software error can cause the speedometer and safety systems to fail, posing a crash risk.

    Product
    John Deere XUV590 and XUV590 S4 Gator™ utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2021·2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.

    Product
    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1523-2021·2021-05-12

    Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error

    Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.

    Product
    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and card
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1527-2021·2021-05-12

    Medtronic Programmers Recalled for Longevity Estimation Error

    Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.

    Product
    Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1528-2021·2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.

    Product
    CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1427-2021·2021-04-21

    RayStation Software Recall Due to Potential Data Synchronization Errors

    RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.

    Product
    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2021·2021-04-21

    EOS Imaging Recalls EOSedge Systems Due to Measurement Errors

    EOS Imaging is recalling 11 EOSedge systems because they may produce inaccurate 2D measurements and image resizing errors when patients are not positioned antero-posteriorly.

    Product
    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisitio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2021·2021-04-14

    Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch

    Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.

    Product
    Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2021·2021-03-24

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.

    Product
    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2021·2021-03-17

    Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall

    Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.

    Product
    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
    Category
    Medical Device
    Distribution
    8 states