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.

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.

376–400 of 1335

  • HighFDA (Devices)·Z-2580-2021·2021-10-06

    Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

    Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

    Product
    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2021·2021-10-06

    MOSAIQ Oncology Information System software defect reverts approved drug strength

    The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2484-2021·2021-09-29

    Philips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams

    Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.

    Product
    Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2021·2021-09-29

    Centricity PACS Medical Imaging System Image Acquisition and Synchronization Failures

    GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.

    Product
    Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2500-2021·2021-09-29

    Siemens CT Scanners: Software Errors May Interrupt Scanning Workflows

    Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.

    Product
    Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2021·2021-09-29

    Philips EPIQ Ultrasound Systems Recalled for Software Lock-up Defect

    Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.

    Product
    EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V749000·2021-09-24

    Hyundai Recalls Sonata Models for Turn Signal Software Defect

    Hyundai is recalling 2015-2017 Sonata models because a software defect may cause turn signals to activate in the opposite direction, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI SONATA, SONATA HYBRID, SONATA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V725000·2021-09-17

    Kia Recalls 2015-2017 Sedona for Turn Signal Software Defect

    Kia is recalling 2015-2017 Sedona vehicles because a software defect may cause turn signals to activate in the opposite direction, increasing crash risk.

    Product
    KIA — KIA SEDONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2021·2021-09-08

    Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

    Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

    Product
    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2357-2021·2021-09-08

    Medical Imaging Software Bug May Cause Incorrect X-ray Exposure

    Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.

    Product
    CombiDiagnost R90 Software Version R1.0 and R1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2165-2021·2021-08-18

    Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch

    Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.

    Product
    Dose IQ Safety Software used with Spectrum IQ Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2021·2021-07-28

    Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

    Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

    Product
    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2021·2021-07-21

    MRI Imaging System UI Defect May Cause Incorrect Image Orientation

    GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.

    Product
    SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1925-2021·2021-06-30

    Medical Device Recall: reSET App Grants Rewards Despite Positive Drug Screens

    The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.

    Product
    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1926-2021·2021-06-30

    reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access

    Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.

    Product
    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighNHTSA·21V486000·2021-06-29

    Porsche Recalls 2020-2021 Taycan Models for Powertrain Software Fault

    Porsche is recalling certain 2020-2021 Taycan models due to a software monitoring fault that can incorrectly shut down the powertrain, causing loss of motive power and increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V472000·2021-06-24

    2021 Buick Enclave and Chevrolet Traverse Air Bag Software Recall

    General Motors is recalling certain 2021 Buick Enclave and Chevrolet Traverse vehicles due to potentially incorrect air bag calibration software that may affect frontal air bag deployment.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAVERSE, ENCLAVE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2021·2021-06-23

    WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality

    Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2021·2021-06-09

    MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

    A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

    Product
    MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 0
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1773-2021·2021-06-09

    Change Healthcare Enterprise Viewer software defect affects image display settings

    A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.

    Product
    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V411000·2021-06-02

    Mercedes-Benz and Freightliner Sprinter Recalled for Rearview Camera Software Defect

    Daimler Vans USA is recalling 2019-2021 Mercedes-Benz and Freightliner Sprinter vans because a software defect may cause the rearview camera image to fail to display.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 2500, SPRINTER 1500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide