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
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinic...
Diagnostic Devices·45 affected·Jun 29, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Inter...
Medical Implants·95 affected·Jun 25, 2018
High RiskFDA
Boston Scientific Corporation
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R...
Cardiac Devices·793 affected·Jun 20, 2018
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, periph...
Cardiac Devices·1 affected·Jun 15, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED ...
Medical Devices·5,200 affected·Jun 7, 2018
RecallFDA
Beckman Coulter Inc.
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive its...
Medical Devices·25 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sortin...
Medical Devices·495 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intellige...
Medical Devices·283 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc...
Medical Devices·58 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B7348...
Medical Devices·14 affected·May 24, 2018
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Medical Devices·1 affected·May 23, 2018
High RiskFDA
Medtech Sas
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is in...
Surgical Devices·29 affected·May 8, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Medical Devices·4,488 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Medical Devices·25,499 affected·Apr 30, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·231 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Ther...
Medical Devices·5,880 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·557 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Th...
Medical Devices·2,772 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·1,256 affected·Apr 24, 2018
High RiskFDA
Tandem Diabetes Care Inc
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary R...
Diabetes Devices·55 affected·Apr 23, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Medical Devices·33 affected·Apr 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient resc...
Medical Devices·4 affected·Apr 20, 2018
High RiskFDA
St Jude Medical Inc.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for i...
Diagnostic Devices·35 affected·Apr 3, 2018
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS2...
Medical Devices·25 affected·Mar 28, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 80...
Diabetes Devices·2,225 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-33...
Medical Devices·5,247 affected·Mar 2, 2018
High RiskFDA
Radiometer Medical Aps
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices...
Medical Devices·2 affected·Feb 27, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully autom...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·291 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic an...
Medical Devices·14 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PA...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Ra Medical Systems Inc
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in t...
Surgical Devices·4 affected·Feb 15, 2018
RecallFDA
Philips Electronics North America Corporation
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel train...
Cardiac Devices·4,315 affected·Feb 7, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6 (Model 10165888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective 16 (Model 10891666)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective (Model 10495568)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Scope Power (Model 10967888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Spirit(Model 10045692 )
Medical Devices·0 affected·Feb 1, 2018
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Raysearch Laboratories Ab
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, ...
Medical Devices·2,484 affected·Jan 26, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Medical Devices·63 affected·Jan 11, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a st...
Medical Devices·165 affected·Jan 10, 2018
High RiskFDA
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PI...
Medical Devices·20,357 affected·Jan 3, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial...
Medical Devices·127 affected·Dec 14, 2017