Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitativ...
Diagnostic Devices·658 affected·Nov 19, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator sy...
Medical Devices·3 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VIT...
Diagnostic Devices·339 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-...
Diagnostic Devices·1,830 affected·Nov 19, 2014
High RiskFDA
Illumina Inc
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in th...
Diagnostic Devices·13 affected·Nov 13, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for ...
Medical Devices·1,064 affected·Nov 12, 2014
High RiskFDA
Vision Rt Inc
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before ...
Medical Devices·55 affected·Nov 11, 2014
RecallFDA
Medtronic Minimed Inc.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider manage...
Diabetes Devices·5 affected·Nov 10, 2014
RecallFDA
Tecan Us, Inc.
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high perfo...
Medical Devices·0 affected·Nov 10, 2014
RecallFDA
Tecan Us, Inc.
Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performa...
Medical Devices·8 affected·Nov 10, 2014
RecallFDA
Illumina Inc
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Diagnostic Devices·19 affected·Nov 6, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Medical Devices·85 affected·Nov 4, 2014
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for tr...
Medical Devices·84 affected·Oct 31, 2014
High RiskFDA
Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Medical Devices·59 affected·Oct 30, 2014
High RiskFDA
Data Innovations, Llc
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that p...
Diagnostic Devices·657 affected·Oct 23, 2014
High RiskFDA
Abbott Molecular
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Medical Devices·9 affected·Oct 23, 2014
High RiskFDA
Ino Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas...
Medical Devices·9 affected·Oct 17, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorpor...
Respiratory Devices·331 affected·Oct 17, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT;...
Medical Devices·7,587 affected·Oct 3, 2014
High RiskFDA
Smiths Medical Asd, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication ...
Medical Devices·24 affected·Sep 29, 2014
High RiskFDA
Iba Dosimetry Gmbh
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Medical Devices·124 affected·Sep 25, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bip...
Surgical Devices·1,483 affected·Sep 17, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is in...
Diagnostic Devices·97 affected·Sep 8, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull...
Medical Devices·62 affected·Aug 27, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diag...
Diagnostic Devices·307 affected·Aug 21, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and mu...
Medical Devices·858 affected·Aug 19, 2014
High RiskFDA
Data Innovations, Llc
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides con...
Diagnostic Devices·84 affected·Aug 15, 2014
CriticalFDA
Biofire Defense
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable...
Medical Devices·43 affected·Aug 13, 2014
High RiskFDA
Philips Electronics North America Corporation
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 4...
Medical Devices·1,642 affected·Jul 31, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography ...
Medical Devices·16 affected·Jul 31, 2014
High RiskFDA
Illumina Inc
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a...
Diagnostic Devices·35 affected·Jul 28, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is ...
Diagnostic Devices·1,099 affected·Jul 27, 2014
High RiskFDA
Philips Healthcare Informatics, Inc.
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Medical Devices·109 affected·Jul 24, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4...
Medical Devices·322 affected·Jul 17, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1...
Medical Devices·168 affected·Jul 16, 2014
High RiskFDA
Philips Ultrasound, Inc.
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify imag...
Medical Devices·59 affected·Jul 9, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended fo...
Diagnostic Devices·2 affected·Jul 8, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety ...
Diagnostic Devices·142 affected·Jul 7, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitr...
Diagnostic Devices·81 affected·Jul 7, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging sys...
Diagnostic Devices·192 affected·Jul 7, 2014
High RiskFDA
Brainlab Ag
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the dis...
Medical Devices·154 affected·Jun 27, 2014
High RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is in...
Medical Devices·13 affected·Jun 27, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Medical Devices·41,992 affected·Jun 13, 2014
High RiskFDA
Biolase Technology Inc
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Medical Devices·117 affected·Jun 12, 2014
CriticalFDA
Ge Healthcare, Llc
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N...
Medical Devices·2,948 affected·Jun 11, 2014
High RiskFDA
Hospira Inc.
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended...
Medical Devices·13 affected·Jun 6, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
Medical Devices·206 affected·Jun 5, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrum...
Surgical Devices·29 affected·Jun 4, 2014