The Recall Desk

Hazard

Software Defect recalls

1,335 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,335
Critical
14
Severe
91
Most recent
2026-09-09

Of the 1,335 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 91 (7%) 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 defect 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.

651–675 of 1335

  • HighFDA (Devices)·Z-3195-2018·2018-09-26

    Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.

    Product
    2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V621000·2018-09-14

    Mitsubishi Recalls Outlander Models Due to Safety System Software Defect

    Mitsubishi is recalling 2017-2018 Outlander, Outlander Sport, Eclipse Cross, and Outlander PHEV vehicles because incorrect software may prevent safety systems like automatic emergency braking from functioning.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER SPORT, ECLIPSE CROSS, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V625000·2018-09-13

    Land Rover Recalls 2018 Models for Silent Automatic Emergency Braking Failure

    Jaguar Land Rover is recalling 2018 Discovery, Range Rover, and Range Rover Sport vehicles because the Automatic Emergency Braking system may disable without warning, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER DISCOVERY, RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V607000·2018-09-11

    Mercedes-Benz Recalls 2018 AMG S63 and S65 for Lane Keeping Software Defect

    Mercedes-Benz is recalling 2018 AMG S63 and S65 vehicles because the Active Lane Keeping Assist software may fail to intervene during unintended lane departures above 65 mph.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, AMG S65
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2018·2018-08-29

    Liebel-Flarsheim Direct Digital Imaging System Recalled for Software Display Discrepancy

    Liebel-Flarsheim is recalling 28 Direct Digital Imaging Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourolog
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2833-2018·2018-08-29

    Liebel-Flarsheim Hydra Vision Urology X-Ray System Recalled for Software Issue

    Liebel-Flarsheim is recalling 313 Hydra Vision Urology X-Ray Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endouro
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2745-2018·2018-08-22

    Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference

    Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.

    Product
    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2018·2018-08-08

    Siemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue

    Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Perspective 16 (Model 10891666)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2018·2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2018·2018-08-01

    Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2530-2018·2018-08-01

    Human Design Medical Recalls Vivo 65 Ventilators Due to Firmware Issue

    Human Design Medical is recalling 45 Vivo 65 home ventilators because some devices have an unreleased version of the Firmware upgrade tool.

    Product
    Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2018·2018-08-01

    Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue

    Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.

    Product
    UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2018·2018-07-25

    RayStation Software Recalled for Potential Radiation Overdose Risk

    RaySearch Laboratories is recalling RayStation treatment planning software versions 4.5 through 8A because a calculation error could lead to significant radiation overdosage during therapy.

    Product
    RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2018·2018-07-04

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is voluntarily recalling two Proteus 235 Proton Therapy Systems to address a software issue and reduce associated risks.

    Product
    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    Product
    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2018·2018-06-13

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

    Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

    Product
    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2018·2018-06-13

    Randox RX Imola Analyzers Recalled for Software Termination Issue

    Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.

    Product
    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1939-2018·2018-06-06

    Siemens SOMATOM go.Now CT Scanner Software Recall

    Siemens Medical Solutions is recalling 4 SOMATOM go.Now CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide