The Recall Desk

Hazard

Software Error recalls

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

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (5%) 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 error 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.

426–450 of 482

  • HighFDA (Devices)·Z-0580-2014·2014-01-01

    EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error

    EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.

    Product
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2014·2014-01-01

    Data Innovations Instrument Manager Driver Software Recall for Sysmex UF-100

    Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.

    Product
    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2014·2013-12-25

    Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch

    Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.

    Product
    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed Mag
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0430-2014·2013-12-11

    Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error

    Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.

    Product
    Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0443-2014·2013-12-11

    Cincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10

    Cincinnati Sub-Zero Products Inc is recalling 12 units of Blanketrol III Data Export Software Version 1.10 because the wrong software version was released to a customer.

    Product
    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol II
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0431-2014·2013-12-11

    Philips Easy Diagnost Eleva Fluoroscopic Software Recall

    Philips Medical Systems is recalling 19 Easy Diagnost Eleva devices because they were delivered with outdated application software.

    Product
    Easy Diagnost Eleva Universal Fluoroscopic applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2014·2013-12-04

    Roche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters

    Roche is recalling 6,595 ACCU-CHEK Aviva Combo Blood Glucose Meters due to a software issue that may cause incorrect insulin bolus advice.

    Product
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0368-2014·2013-11-27

    Philips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors

    Philips is recalling EPIQ 7 Ultrasound Systems because using the International System Date Format may cause calculation errors in Gestational Age and Established Due Date.

    Product
    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2014·2013-11-06

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2014·2013-10-23

    GE Optima CT660 Recalled for Potential Series UID Generation Error

    GE Healthcare is recalling Optima CT660 scanners because the DMPR and Screen Save functions may generate duplicate Series UIDs, potentially causing PACS systems to combine patient series incorrectly.

    Product
    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2253-2013·2013-09-25

    GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure

    GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.

    Product
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2013·2013-09-04

    GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations

    GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.

    Product
    GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1945-2013·2013-08-21

    Siemens AXIOM Artis zeego x-ray system safety notice issued

    Siemens issued a customer safety notice regarding system information overlays after brake functional checks on the AXIOM Artis zeego x-ray system.

    Product
    Siemens AXIOM Artis zeego x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2013·2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error

    Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1914-2013·2013-08-14

    Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Interface Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide