The Recall Desk

Hazard

Software Error recalls

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

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.

51–75 of 102

  • SevereFDA (Devices)·Z-2103-2023·2023-07-19

    Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction

    Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.

    Product
    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2023·2023-05-03

    Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

    The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

    Product
    HAMILTON-C6, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V062000·2023-02-09

    Spartan Motorhome Chassis Software Error Causes Loss of Drive Power and Visibility

    Shyft Group is recalling 2022–2024 Spartan motorhome chassis due to a software error that may cause loss of drive power or safety functions like headlights and wipers. Owners should contact Shyft Group at 1-800-237-7806 for a free software update.

    Product
    SPARTAN — 2023 SPARTAN K1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2023·2023-01-18

    BD Pyxis MedBank System may dispense wrong medication due to software error

    The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.

    Product
    BD Pyxis MedBank System - Product Label/labeling pending
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2023·2023-01-18

    Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled

    Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1786-2022·2022-10-05

    Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

    Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

    Product
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2022·2022-09-21

    ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment

    A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.

    Product
    ZAP-X Radiosurgery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2022·2022-09-21

    Pinnacle3 Radiation Therapy Planning System dose-calculation software error

    Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.

    Product
    Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1748-2022·2022-09-21

    SCENARIA View software error may require additional patient radiation exposure

    SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.

    Product
    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2022·2022-09-07

    Pentacam HR Medical Device Software Error Impacts Surgical Planning

    A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.

    Product
    Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1672-2022·2022-09-07

    Medical device software error affects toric IOL surgical planning accuracy

    A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.

    Product
    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    36 states
  • SevereNHTSA·22V662000·2022-09-01

    Honda CRF1100 Africa Twin Motorcycles Recalled for Engine Control Software Bug

    Honda is recalling 2020-2021 CRF1100 Africa Twin motorcycles due to an ECU software error that may cause engine stall or loss of drive power. Owners can get a free software update from dealers.

    Product
    HONDA — 2021 HONDA CRF1100 AFRICA TWIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2022·2022-08-31

    Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators

    The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.

    Product
    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V638000·2022-08-25

    2021 Jeep Gladiator rearview camera display failure from radio software error

    Certain 2021 Jeep Gladiator vehicles have a radio software error that may prevent the rearview camera image from displaying. This reduces rear visibility and increases the risk of backing collisions.

    Product
    JEEP — 2021 JEEP GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2022·2022-08-17

    Aeos Robotic Digital Microscope software errors affect autofocus and rebalancing

    Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.

    Product
    Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1452-2022·2022-07-27

    SurgiCount+ System software error bypasses sponge tracking alerts

    A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.

    Product
    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1333-2022·2022-07-13

    GE Centricity Medical Imaging Software Displays Inaccurate Measurements

    GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.

    Product
    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1344-2022·2022-07-13

    Abbott TactiCath Ablation Catheter System Error Display Malfunction

    Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.

    Product
    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2022·2022-07-06

    TEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager

    Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.

    Product
    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V449000·2022-06-23

    Honda GL1800 motorcycles recalled for engine stall software defect

    Honda is recalling certain 2020-2022 GL1800 Gold Wing motorcycles with manual transmissions due to a software error that may cause engine stalls. Engine stalls while riding can increase the risk of crashes.

    Product
    HONDA — 2021 HONDA GL1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V404000·2022-06-08

    2020-2022 Porsche Taycan center screen display malfunction increases crash risk

    Porsche is recalling 2020-2022 Taycan vehicles for a software error causing the center screen and touch panel to go black or flicker. This blocks the driver's view of rear-view camera functions, increasing crash risk.

    Product
    PORSCHE — 2020 PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2022·2022-04-06

    Radiographic system software error may cause unintended tube stand movement

    Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.

    Product
    Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide