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.

376–400 of 482

  • HighFDA (Devices)·Z-1631-2015·2015-05-27

    Philips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations when using Metric settings.

    Product
    EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2015·2015-05-27

    Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error

    Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1579-2015·2015-05-13

    Philips EPIQ 7 Ultrasound System Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 7 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2015·2015-05-06

    Lumenis Light Sheer Desire Diode Laser System Recalled for Software Error

    Lumenis is recalling 117 Light Sheer Desire Diode Laser Systems because software parameters exceed manual settings, potentially causing burns.

    Product
    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2015·2015-03-25

    St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update

    St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.

    Product
    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2015·2015-03-11

    Elekta Focal Sim radiation therapy system recalled for image statistics error

    Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.

    Product
    Focal Sim radiation therapy treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1228-2015·2015-03-11

    Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display

    Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.

    Product
    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1068-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. A software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help asse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1013-2015·2015-02-04

    Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

    Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

    Product
    Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1016-2015·2015-02-04

    Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors

    Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.

    Product
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0993-2015·2015-01-28

    Maquet Tegris System Recalled Due to Software Error in Operating Table Commands

    Maquet Medical Systems USA is recalling six units of the Tegris System because a software error switches leg movement commands for the Magnus OR table.

    Product
    TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0947-2015·2015-01-21

    Phadia 1000 Instrument Recalled for Rack Sequencing Error

    Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.

    Product
    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utili
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0991-2015·2015-01-21

    Tecan Infinite 200 Microplate Reader Recalled for Incorrect Firmware Version

    Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).

    Product
    Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a ge
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0992-2015·2015-01-21

    Tecan Infinite 200PRO Microplate Reader Recalled for Firmware Error

    Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.

    Product
    Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0910-2015·2015-01-14

    McKesson Cardiology ECG Management Software Recalled for Incorrect Time Stamps

    McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software versions 13.1 and 13.1.1 because a software error causes incorrect ECG procedure time stamps.

    Product
    McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0463-2015·2014-12-03

    Abbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing

    Abbott Molecular is recalling m2000sp CD-ROMs because some Application Specifications are incompatible with software versions 6.0 and 7.0, causing error code 9000.

    Product
    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2015·2014-11-26

    Elekta MOSAIQ Oncology System Recalled for Dose Rounding Error

    Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.

    Product
    MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0211-2015·2014-11-19

    Maquet Cardiohelp-I System Recalled for Potential Software Display Error

    Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.

    Product
    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2015·2014-11-12

    IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors

    Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.

    Product
    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte conce
    Category
    Medical Device
    Distribution
    Distributed nationwide