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.

601–625 of 1375

  • 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…
    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
  • SevereFDA (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…
    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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2019·2019-05-22

    Philips SureSigns VS3 Monitor Recall Due to Software Defect

    Philips is recalling 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, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2019·2019-05-22

    Philips SureSigns VS3 Monitor Recall for High Pulse Rate Measurement Failure

    Philips is recalling 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, Product Number 863071. 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
  • 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-1318-2019·2019-05-22

    Philips SureSigns VS3 Monitor Software Defect Recalled

    Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2019·2019-05-22

    Philips SureSigns VS4 Monitor Software Defect Recall

    Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    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
  • ModerateFDA (Devices)·Z-1300-2019·2019-05-15

    Siemens Atellica IM 1600 Analyzer Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.

    Product
    Atellica IM 1600 Analyzer, Material Number 11066000
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1299-2019·2019-05-15

    Siemens Atellica IM 1300 Analyzer Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.

    Product
    Atellica IM 1300 Analyzer, Material Number 11066001
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1301-2019·2019-05-15

    Siemens Atellica Sample Handler Prime Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.

    Product
    Atellica Sample Handler Prime, Material Number 11069001
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1247-2019·2019-05-08

    Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk

    Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1244-2019·2019-05-08

    Siemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode

    Siemens is recalling 53 SOMATOM Confidence CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

    Siemens is recalling 53 SOMATOM Edge Plus CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide