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 Medical Solutions Usa, Inc
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste...
Medical Devices·9 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sy...
Medical Devices·24 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sys...
Medical Devices·30 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sy...
Medical Devices·53 affected·May 28, 2019
High RiskFDA
Obalon Therapeutics Inc
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended...
Medical Devices·45 affected·May 23, 2019
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ...
Cardiac Devices·3,146 affected·Apr 29, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·518 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·21,857 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperat...
Medical Devices·12,719 affected·Apr 19, 2019
High RiskFDA
Philips North America, Llc
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Medical Devices·12,543 affected·Apr 19, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2...
Medical Devices·314 affected·Apr 17, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H78770010600...
Cardiac Devices·10,580 affected·Apr 17, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030...
Cardiac Devices·1,846 affected·Apr 17, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78...
Medical Devices·178 affected·Apr 17, 2019
High RiskFDA
Hitachi America, Ltd., Power Systems Division
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Medical Devices·3 affected·Apr 15, 2019
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is ind...
Medical Devices·257 affected·Apr 3, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP surgical system
Surgical Devices·17 affected·Apr 1, 2019
CriticalFDA
Hamilton Medical Ag
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilat...
Respiratory Devices·4,338 affected·Mar 25, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system ...
Cardiac Devices·2 affected·Mar 22, 2019
High RiskFDA
Flowonix Medical Inc
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Medical Devices·809 affected·Mar 21, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, Material Number 11066000
Medical Devices·366 affected·Mar 7, 2019
High RiskFDA
Topcon Medical Systems, Inc.
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and manag...
Diagnostic Devices·450 affected·Mar 6, 2019
High RiskFDA
Viewray, Inc.
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Medical Devices·24 affected·Mar 3, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitativ...
Diagnostic Devices·267 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·55 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, sem...
Diagnostic Devices·4 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·62 affected·Feb 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Us...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sect...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, ped...
Cardiac Devices·10,699 affected·Feb 8, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Medical Devices·3 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Medical Devices·1 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Medical Devices·4 affected·Feb 6, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, ...
Cardiac Devices·70 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA1...
Cardiac Devices·1,384 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10...
Cardiac Devices·2,262 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B,...
Cardiac Devices·1,869 affected·Jan 28, 2019
High RiskFDA
Bio-rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Medical Devices·213 affected·Jan 10, 2019
High RiskFDA
Neusoft Medical Systems Imp & Ex
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be u...
Medical Devices·3 affected·Jan 9, 2019
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer de...
Diagnostic Devices·3 affected·Jan 2, 2019
High RiskFDA
Kavo Dental Technologies Llc
cone-beam CT system
Medical Devices·230 affected·Dec 31, 2018
High RiskFDA
Steris Corporation
AMSCO 5000 Series Washer/Disinfector Model # 5052
Medical Devices·68 affected·Dec 20, 2018
High RiskFDA
Steris Corporation
AMSCO 3000 Series Washer/Disinfector Model # 3052
Medical Devices·11 affected·Dec 20, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomogra...
Cardiac Devices·24 affected·Dec 19, 2018
High RiskFDA
Baxter Healthcare Corporation
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in th...
Medical Devices·1,085 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the...
Medical Devices·7,688 affected·Dec 11, 2018
High RiskFDA
Agfa-gevaert, N.v.
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system u...
Medical Devices·10 affected·Dec 4, 2018