Hazard

Software Defect recalls

316 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 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.

26–50 of 316

HighFDA (Devices)·Z-1383-2026·2026-02-25
Bronchoscopy System Software Bug Could Cause Unexpected Robotic Arm Positioning
Auris Health MONARCH Platform bronchoscopy systems are affected by a software defect where the application may reinitialize to an incorrect position after restart, potentially causing the robotic arm to contact the patient's airway.
Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2026·2026-02-11
MiniMed 780G Insulin Pump Software Error May Suspend Delivery
A software timing issue in MiniMed 780G insulin pumps (software version 6.60) may trigger pump errors that suspend insulin delivery. 577 units are affected, distributed in the US and Israel.
Product
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-1211-2026·2026-02-04
Philips Ingenia Elition S MR Systems May Display Incorrect Stiffness Values
Philips recalled five Ingenia Elition S MR systems with software versions R11.1 and R12.1 due to potential stiffness value calculation errors. The issue affects elastography data displayed in PACS viewers worldwide.
Product
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V149000·2026-02-02
2024 Livewire S2 Del Mar motorcycle powertrain shutdown recall
LiveWire is recalling 2024 S2 Del Mar motorcycles due to a software defect that may unexpectedly shut down the powertrain, causing loss of drive power and increasing crash risk. An over-the-air software update will be provided.
Product
LIVEWIRE — 2024 LIVEWIRE S2 DEL MAR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2026·2026-01-28
Radiation Therapy Planning Software Dose Calculation Error in RayStation
RayStation radiation therapy planning software version 10.1 may fail to properly invalidate radiation dose calculations when regions of interest lack contours but have material overrides or are bolus/fixation/support types.
Product
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1107-2026·2026-01-28
Radiation therapy planning software recalled for dose calculation defect
RayStation radiation therapy planning software version 10B SP1 has a defect where dose calculations fail to invalidate properly when certain regions of interest are modified, potentially affecting treatment planning accuracy.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1118-2026·2026-01-28
ICU Medical Plum Duo infusion pump software prevents flush feature programming
ICU Medical Plum Duo infusion pumps have a software issue preventing clinicians from programming the automatic flush feature after piggyback therapy, affecting this critical safety function.
Product
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2026·2026-01-28
RayStation Radiation Therapy Treatment Planning System Dose Invalidation Error Recall
RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may fail to properly invalidate calculated radiation doses for certain region types. This could result in use of outdated dose calculations in patient treatment planning.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1110-2026·2026-01-28
RayStation radiation therapy treatment planning software dose invalidation defect
RayStation v17.0.0 and v17.0.1 fail to properly invalidate dose calculations for certain regions of interest. The system may not recalculate radiation doses when geometry changes or material overrides are removed.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1156-2026·2026-01-28
Medical Device Software Update Silently Changes Alert Settings Without User Notification
A software update to Philips Patient Information Center iX modifies Mobile Event Notification filter settings without alerting users during upgrade. This could result in missed critical patient alerts to medical staff.
Product
Patient Information Center iX; Software Version Number: 4.5.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1109-2026·2026-01-28
RayStation radiation therapy planning system dose invalidation software defect
RayStation treatment planning system version 16.0.0 has a software defect preventing dose recalculation for certain region of interest configurations. The defect affects dose invalidation when specific ROI types lack contours combined with material overrides or bolus classifications.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1091-2026·2026-01-21
Philips Azurion medical imaging systems recalled for software defects
Philips is recalling Azurion diagnostic imaging systems with software versions R2.1.10 and R2.2.10 due to six software defects that may cause system restarts, storage issues, and positioning errors. Approximately 10,466 units distributed worldwide are affected.
Product
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2026·2026-01-14
BD Pyxis ES Enterprise Server Software Defect May Delay Medication Updates
A software issue in the BD Pyxis ES Enterprise Server may prevent timely updates of patient and medication information. The defect affects 2,079 systems distributed nationwide and in Canada and Bermuda.
Product
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·24V801000·2026-01-10
2025 Lincoln Aviator rearview camera software defect affects rear visibility
The 2025 Lincoln Aviator's rearview camera may fail at speeds of 10 MPH or greater, reducing rear visibility and increasing crash risk. Ford is providing free software updates via over-the-air or dealer service.
Product
LINCOLN — 2025 LINCOLN AVIATOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V560000·2026-01-07
2023 Nissan Ariya Inverter Software Defect May Cause Loss of Drive Power
Nissan is recalling 2023 Ariya vehicles due to inverter software that may misdiagnose errors and shut down the EV system, causing loss of drive power and increased crash risk.
Product
NISSAN — 2023 NISSAN ARIYA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·26V209000·2026-01-04
2026 Audi Q3 Sunroof Software May Block Visibility During Closing
Audi is recalling certain 2026 Q3 vehicles due to incorrect sunroof control software that may prevent the operator from seeing the sunroof while closing it. This creates a risk of injury to occupants.
Product
AUDI — 2026 AUDI Q3
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2026·2025-12-31
LifeShield Infusion Software Recalled for Concentration Limit Precision Defect
LifeShield Drug Library Management software limits drug concentration precision to one decimal place instead of three, potentially forcing users to deviate from manufacturer recommendations and risking medication delivery errors.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2026·2025-12-24
Ivenix Infusion System Software Versions 5.10.1 and Earlier Recalled
Fresenius Kabi is recalling Ivenix Infusion System software versions 5.10.1 and earlier due to software anomalies that could cause serious patient harm or death.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Category
Medical Device
Distribution
20 states
HighNHTSA·25V389000·2025-12-06
2024-2025 Dodge Charger amplifier software missing, disabling pedestrian alerts
Chrysler is recalling certain 2024-2025 Dodge Charger vehicles due to missing amplifier software that can prevent pedestrian warning sounds. The vehicle may fail to alert nearby pedestrians, increasing crash risk.
Product
DODGE — 2024 DODGE CHARGER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2026·2025-12-03
Medical Imaging Software Bug Risks Clinical Data Loss
A bug in IntelePACS medical imaging software may delete clinical information when modifying patient studies, potentially impacting clinical decision-making.
Product
IntelePACS - InteleConnect / TechPortal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2026·2025-11-26
MOSAIQ Oncology Software Defect: Care Plan Medication Order Frequency Mismatch
ELEKTA SOLUTIONS AB is recalling MOSAIQ Oncology Information System software because appending care plans with wave medication orders may cause the medication occurrence and frequency to not match the intended schedule.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2026·2025-11-19
Medical Device Software Bug Prevents Proper Result Flagging in Laboratory Analyzer
The Alinity hq Analyzer has a software defect that fails to properly flag test results when saturation is present, potentially resulting in incorrect laboratory findings.
Product
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2026·2025-11-05
Laboratory Sample Preparation System Software and Instructions with Processing Defects
Beckman Coulter's CellMek SPS Sample Preparation System has incorrect dead volume specifications in its instructions and a software defect affecting specimen processing. The errors may lead to incorrect diagnoses or errors in patient management.
Product
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0324-2026·2025-11-05
Surgical Navigation Software Update Issued for Image Misalignment Risk
Surgical Theater's SpineAR SNAP orthopedic surgical navigation software has a potential image misalignment defect under specific conditions. The software could misalign secondary image layers with the primary layer, affecting surgical guidance.
Product
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2026·2025-11-05
Surgical Navigation System Software Defect May Cause Image Misalignment
Surgical Theater's SyncAR SNAP surgical navigation system software has an anomaly that may cause secondary imaging layers to misalign with primary images under specific conditions. The FDA is recalling 14 units distributed across the United States and internationally.
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide