The Recall Desk

Hazard

Software Malfunction recalls

109 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 malfunction 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.

76–100 of 109

  • HighFDA (Devices)·Z-1750-2022·2022-09-21

    Surpria 64 Software Error May Prevent Image Reconstruction During Scanning

    Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.

    Product
    Surpria 64: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1640-2022·2022-09-07

    bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies

    bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.

    Product
    VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·22135·2022-05-19

    Hover-1 Superfly Hoverboards Recalled Due to Fall and Injury Hazards

    DGL Group is recalling approximately 93,000 Hover-1 Superfly Hoverboards sold between October 2020 and October 2021 at Best Buy due to a software malfunction that causes uncontrolled momentum when the rider is not actively controlling the board.

    Product
    Hover-1 Superfly Hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2022·2022-05-04

    CT Scanner Software Update May Display Incorrect Laser Offset Coordinates

    Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2022·2022-05-04

    Drager Infinity CentralStation Software Temporary Monitoring Functionality Loss

    Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.

    Product
    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2022·2022-04-27

    Merlin PCS 3650 Programmer May Fail to Terminate Pacing Test Properly

    A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2022·2022-04-27

    Medical imaging system software errors may delay treatment procedures

    Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.

    Product
    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2022·2022-04-27

    Siemens Artis pheno diagnostic imaging system software malfunction recall

    Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.

    Product
    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V189000·2022-03-25

    2021-2022 Mercedes-Benz steering hand-detection system software malfunction

    Mercedes-Benz is recalling certain 2021-2022 vehicles with heated leather steering wheels because a software error prevents the DISTRONIC hand-off detection system from functioning. This can disable warnings for drivers to grab the wheel and prevent emergency responder assistance.

    Product
    MERCEDES-BENZ — 2021 MERCEDES-BENZ E450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2022·2022-03-23

    Diagnostic ultrasound system ACUSON Juniper fails to save study clips

    The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

    Product
    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2022·2022-01-26

    FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error

    Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.

    Product
    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2022·2022-01-12

    Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures

    Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0383-2022·2021-12-29

    Stealthstation and Synergy Cranial surgical navigation system software synchronization error

    Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.

    Product
    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0287-2022·2021-12-01

    CT Scanner Software May Cause Workflow Interruptions and Diagnosis Delays

    Siemens SOMATOM Drive CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnosis and require additional patient scans. Approximately 75 units are affected nationwide.

    Product
    SOMATOM Drive with software syngo.CT VB20 Model #10431700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2022·2021-12-01

    CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays

    Siemens SOMATOM Definition Flash CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnoses and require additional rescans and contrast media. This recall affects 121 units distributed nationwide.

    Product
    SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2022·2021-12-01

    Philips Azurion System Recall for 3D Image Reconstruction Defect

    Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.

    Product
    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2022·2021-12-01

    Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

    Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

    Product
    SOMATOM Confidence with software syngo.CT VB20 Model #10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2022·2021-12-01

    Medical Imaging System May Fail to Release X-rays Under Specific Conditions

    Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.

    Product
    Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2022·2021-12-01

    Siemens Artis zee x-ray system may delay imaging delivery during procedures

    Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.

    Product
    Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2022·2021-12-01

    Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation

    Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.

    Product
    Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2022·2021-10-27

    Canon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures

    Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.

    Product
    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2021·2021-09-15

    Solero Generator PG requires software service for startup error

    Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.

    Product
    Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2021·2021-09-08

    CoolSculpting Elite System Software Error May Misreport Thermal Events

    The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

    Product
    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
    Category
    Medical Device
    Distribution
    43 states
Software Malfunction recalls · The Recall Desk