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
Mindray Ds Usa, Inc. Dba Mindray North America
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mon...
Medical Devices·9 affected·Oct 1, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The moni...
Medical Devices·14 affected·Oct 1, 2019
High RiskFDA
Life Technologies Holdings Pte Ltd
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARU...
Medical Devices·400 affected·Sep 26, 2019
High RiskFDA
Life Technologies Holdings Pte Ltd
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
Medical Devices·400 affected·Sep 26, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Medical Devices·14 affected·Sep 24, 2019
High RiskFDA
Tomtec Imaging Systems Gmbh
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable U...
Medical Devices·62 affected·Sep 23, 2019
High RiskFDA
Blue Ortho
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Re...
Medical Devices·7 affected·Sep 22, 2019
High RiskFDA
Boston Scientific Corporation
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Medical Devices·150 affected·Sep 18, 2019
High RiskFDA
Novarad Corporation
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display im...
Diagnostic Devices·197 affected·Sep 10, 2019
High RiskFDA
Labstyle Innovations
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Diabetes Devices·126,271 affected·Aug 29, 2019
High RiskFDA
Varian Medical Systems, Inc.
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Numb...
Medical Devices·151 affected·Aug 12, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible ...
Surgical Devices·1 affected·Jul 31, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible thro...
Surgical Devices·0 affected·Jul 31, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible thro...
Surgical Devices·0 affected·Jul 31, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Medical Devices·9 affected·Jul 26, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Medical Devices·4 affected·Jul 26, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOM...
Medical Devices·2,867 affected·Jul 25, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies...
Diagnostic Devices·139 affected·Jul 23, 2019
High RiskFDA
Aggredyne, Inc.
AggreGuide A-100 Instrument
Medical Devices·47 affected·Jul 23, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-...
Medical Devices·7,168 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000...
Medical Devices·19,351 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006...
Medical Devices·473 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-931...
Medical Devices·502 affected·Jul 19, 2019
High RiskFDA
Philips North America, Llc
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15...
Cardiac Devices·834 affected·Jul 16, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System, clinical chemistry analyzer
Medical Devices·2,531 affected·Jul 8, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used wi...
Diagnostic Devices·95 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·2 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·55 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Medical Devices·0 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·1,051 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250AT Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Diabetes Devices·72,850 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Diabetes Devices·27 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Diabetes Devices·73,028 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Insulin Pump, model # MMT-508
Diabetes Devices·64,174 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
Diabetes Devices·88,243 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Diabetes Devices·68,598 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm 512 Insulin pump
Diabetes Devices·34,777 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm Insulin pump, model number MMT-712
Diabetes Devices·74,496 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Diabetes Devices·36,143 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
MiniMed Paradigm Model 511 Insulin Pump
Diabetes Devices·30,479 affected·Jun 27, 2019
High RiskFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Diabetes Devices·225,498 affected·Jun 27, 2019
CriticalFDA
Fenwal Inc
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Softw...
Medical Devices·83 affected·Jun 24, 2019
CriticalFDA
Fenwal Inc
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of t...
Medical Devices·9,461 affected·Jun 24, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scala...
Diagnostic Devices·1,763 affected·Jun 10, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomograph...
Medical Devices·69 affected·Jun 4, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomograph...
Medical Devices·69 affected·Jun 4, 2019