The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 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 106 (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 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.

701–725 of 1375

  • 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…
    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-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…
    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…
    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
  • 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…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1940-2018·2018-06-06

    Siemens SOMATOM Go.Up CT Scanner Recalled for Software Issue

    Siemens is recalling 33 SOMATOM Go.Up CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighNHTSA·18V337000·2018-05-23

    Land Rover Recalls 2017 Models for Fuel Gauge Software Error

    Jaguar Land Rover is recalling 2017 Range Rover, Range Rover Sport, and Discovery vehicles because a software error may cause the engine to shut off unexpectedly.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, DISCOVERY, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2018·2018-05-23

    Siemens Recalls CT Scanner Software for Radiation Risk

    Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1745-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1700-2018·2018-05-16

    Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2018·2018-05-16

    Siemens Syngo.Via Software Recall for Report Functionality Defect

    Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.

    Product
    Syngo.Via VB20A model 1049610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2018·2018-05-09

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1588-2018·2018-05-09

    Siemens Atellica IM 1600 Analyzer Recalled for Reporting Factor Errors

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.

    Product
    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1613-2018·2018-05-09

    Roche cobas b 221 AutoQC Module Recall for Software Failure

    Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.

    Product
    cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2018·2018-05-09

    Roche Omni S2 Analyzer Recall Due to Software Failure

    Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.

    Product
    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit…
    Category
    Medical Device
    Distribution
    Distributed nationwide