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
Illumina, Inc.
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Medical Devices·1,067 affected·Apr 5, 2023
High RiskFDA
Technidata S.a.
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecologic...
Medical Devices·1 affected·Mar 27, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 7220...
Medical Devices·1,063 affected·Mar 21, 2023
High RiskFDA
Hamilton Medical Ag
HAMILTON-C6, REF: 160021
Medical Devices·103 affected·Mar 14, 2023
High RiskFDA
Radiometer Medical Aps
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devic...
Medical Devices·1,806 affected·Mar 8, 2023
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number:...
Medical Devices·47 affected·Mar 1, 2023
High RiskFDA
Raysearch Laboratories Ab
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10....
Medical Devices·10,770 affected·Feb 17, 2023
High RiskFDA
Brainlab Ag
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Medical Devices·56 affected·Feb 14, 2023
High RiskFDA
Sensus Healthcare, Inc.
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System w...
Medical Devices·23 affected·Feb 10, 2023
High RiskFDA
Boston Scientific Corporation
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Medical Devices·1,531 affected·Feb 2, 2023
High RiskFDA
Carefusion 303, Inc.
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Medical Devices·83,185 affected·Jan 24, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the followin...
Medical Devices·29 affected·Dec 22, 2022
High RiskFDA
Withings
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen satu...
Cardiac Devices·38,886 affected·Dec 19, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Medical Devices·18 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Medical Devices·22 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Medical Devices·362 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Medical Devices·1,337 affected·Dec 3, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family o...
Medical Devices·8 affected·Nov 9, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Diagnostic Devices·883 affected·Oct 12, 2022
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP...
Medical Devices·422 affected·Oct 10, 2022
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Medical Devices·4 affected·Sep 8, 2022
High RiskFDA
Micro-x Ltd.
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Medical Devices·42 affected·Aug 31, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Surgical Devices·115 affected·Aug 26, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Surgical Devices·30 affected·Aug 26, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Surgical Devices·25 affected·Aug 26, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models...
Medical Devices·2,008 affected·Jul 27, 2022
RecallFDA
Nuvasive Inc
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Medical Devices·7 affected·Jul 19, 2022
High RiskFDA
Aesculap Implant Systems Llc
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Medical Devices·5 affected·Jul 14, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Medical Devices·0 affected·Jul 13, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Medical Devices·16 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Medical Devices·46 affected·Jul 12, 2022
High RiskFDA
Oculus Optikgeraete Gmbh
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Medical Devices·92 affected·Jul 8, 2022
High RiskFDA
Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse ge...
Medical Implants·17,172 affected·Jul 7, 2022
High RiskFDA
Zap Surgical Systems
ZAP-X Radiosurgery System
Medical Devices·8 affected·Jul 5, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER37000 programmer Model MER3400 software
Medical Devices·622 affected·Jun 17, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
Medical Devices·29,996 affected·Jun 17, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin.net model MN5000 Software
Medical Devices·0 affected·Jun 17, 2022
High RiskFDA
Nordicneurolab As
nordicBrainEX, software versions 2.21 through 2.3.10
Medical Devices·243 affected·Jun 16, 2022
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locat...
Surgical Devices·44 affected·Jun 15, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiolo...
Cardiac Devices·2 affected·Jun 15, 2022
High RiskFDA
Ge Healthcare, Llc
Centricity PACS Software Version 7.0 SP0.0.4.7
Medical Devices·47 affected·Jun 14, 2022
High RiskFDA
Sight Diagnostics Ltd
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Medical Devices·72 affected·Jun 14, 2022
High RiskFDA
Breas Medical, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanic...
Respiratory Devices·1,113 affected·Jun 2, 2022
High RiskFDA
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
Medical Devices·529 affected·May 31, 2022
High RiskFDA
Baxter Healthcare Corporation
NaviCare Nurse Call/Voalte Nurse Call
Medical Devices·283 affected·May 31, 2022
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump w...
Diabetes Devices·31,100 affected·May 24, 2022
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Wind...
Medical Devices·686 affected·May 24, 2022
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump w...
Diabetes Devices·8,399 affected·May 24, 2022