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.

551–575 of 1335

ModerateFDA (Devices)·Z-2064-2019·2019-08-21
Fenwal Volumat MC Agilia Infusion Pump Software Recall
Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.
Product
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2019·2019-08-14
Abbott Alinity ci-series System Control Modules Recalled for Software Defect
Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.
Product
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a sca
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2184-2019·2019-08-14
Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue
Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Product
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2182-2019·2019-08-14
Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Product
VITROS 4600 Chemistry System, clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2019·2019-08-07
Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.
Product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1997-2019·2019-08-07
Philips Recalls Azurion X-ray Systems Due to Software Defect
Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.
Product
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2063-2019·2019-07-31
Merge OrthoPACS Software Recalled for Image Display Ordering Issues
Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.
Product
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2062-2019·2019-07-31
Merge PACS Software Recalled for Mammography Image Display Errors
Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.
Product
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2082-2019·2019-07-31
Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts
Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.
Product
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2019·2019-07-24
Elekta Unity Radiation Therapy System Software Recall
Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.
Product
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical pract
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1906-2019·2019-07-10
Bio-Rad Recalls EVOLIS Microplate System Due to Software Error
Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.
Product
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2019·2019-07-03
GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning
GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.
Product
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, com
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2019·2019-06-12
Flowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.
Product
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1699-2019·2019-06-12
Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message
Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on software version 2.72.
Product
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1493-2019·2019-06-05
Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect
Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.
Product
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1384-2019·2019-05-29
Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors
Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.
Product
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s g
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2019·2019-05-29
Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation
Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.
Product
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2019·2019-05-29
Roche Cobas infinity Software Recall for Missing Quality Control Alarms
Roche Diagnostics is recalling 15 units of Cobas infinity software versions 2.0 through 2.5 because quality control alarms may fail to display after a bottle change.
Product
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1279-2019·2019-05-29
Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
Neusoft Medical Systems is recalling 37 NeuViz 64 CT scanners due to a software defect that can cause image loss during specific scans.
Product
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by comp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1280-2019·2019-05-29
Neusoft NeuViz 128 CT Scanner Recalled for Software Defect
Neusoft Medical Systems is recalling six NeuViz 128 CT scanners due to a software defect that may cause image loss during specific scans.
Product
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by com
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1281-2019·2019-05-29
NeuViz 16 Essence CT Scanner Recalled for Software Defect
Neusoft Medical Systems is recalling two NeuViz 16 Essence CT scanners due to a software defect that may cause image loss during specific scans.
Product
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1317-2019·2019-05-22
Philips SureSigns VS3 NBP Recall for Pulse Rate Measurement Limitation
Philips is recalling SureSigns VS3 NBP monitors because software prevents the display and alarm for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2019·2019-05-22
Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling 366 SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling SureSigns VS3 patient monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide