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
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Medical Devices·83,015 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Medical Devices·1,286,898 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Medical Devices·114,835 affected·Feb 4, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory e...
Medical Devices·12,822 affected·Feb 3, 2020
High RiskFDA
89 North
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Medical Devices·188 affected·Jan 31, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medical Implants·23,180 affected·Jan 30, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity ...
Medical Devices·2,676 affected·Jan 24, 2020
High RiskFDA
Braemar Manufacturing, Llc
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Medical Devices·10,582 affected·Jan 22, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part n...
Medical Devices·16,700 affected·Jan 22, 2020
High RiskFDA
Philips North America, Llc
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different config...
Medical Devices·44,442 affected·Jan 13, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Diagnostic Devices·12 affected·Jan 10, 2020
High RiskFDA
Medtech Sas
ROSA Brain 3.0 Application-Brain
Medical Devices·47 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is in...
Diagnostic Devices·2,149 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: T...
Diagnostic Devices·0 affected·Jan 6, 2020
High RiskFDA
Medtech Sas
ROSA One 3.1 Brain Application
Medical Devices·39 affected·Jan 6, 2020
High RiskFDA
Koios Medical, Inc.
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Medical Devices·10 affected·Dec 31, 2019
High RiskFDA
Flowonix Medical Inc
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Medical Implants·6,670 affected·Dec 24, 2019
High RiskFDA
Flowonix Medical Inc
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country l...
Medical Implants·1,083 affected·Dec 24, 2019
High RiskFDA
Randox Laboratories, Limited
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random a...
Medical Devices·4,040 affected·Dec 19, 2019
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Diagnostic Devices·116 affected·Dec 19, 2019
High RiskFDA
Abaxis Inc
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Medical Devices·15 affected·Dec 11, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·16 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·5 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2...
Respiratory Devices·48 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·8 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least...
Respiratory Devices·105 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least ...
Respiratory Devices·29 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients wei...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·27 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·31 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·1 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing...
Respiratory Devices·15 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at...
Respiratory Devices·3 affected·Nov 19, 2019
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 ...
Medical Devices·956 affected·Nov 18, 2019
High RiskFDA
Ge Healthcare, Llc
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed hea...
Medical Devices·11,347 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and ...
Medical Devices·41,848 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data with...
Medical Devices·10,661 affected·Nov 12, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum an...
Diagnostic Devices·712 affected·Oct 28, 2019
High RiskFDA
Cuattro Llc
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Medical Devices·9 affected·Oct 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an au...
Diagnostic Devices·1,528 affected·Oct 11, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862,...
Medical Devices·12,204 affected·Oct 9, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·2,760 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·986 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·1,014 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·336 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·988 affected·Oct 4, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The ...
Medical Devices·13 affected·Oct 1, 2019