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
Ortho-clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Diagnostic Devices·1 affected·Jan 26, 2024
CriticalFDA
Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch C...
Cardiac Devices·1,560 affected·Jan 3, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Diagnostic Devices·61 affected·Jan 3, 2024
High RiskFDA
Truabutment Inc.
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software V...
Medical Devices·61 affected·Dec 27, 2023
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Medfusion Model 3500 Syringe pump
Medical Devices·93,177 affected·Dec 19, 2023
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Medfusion Model 4000 syringe pump
Medical Devices·60,146 affected·Dec 19, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Medical Devices·28 affected·Dec 8, 2023
High RiskFDA
Wavi Co.
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart R...
Cardiac Devices·281 affected·Dec 8, 2023
High RiskFDA
Boston Scientific Corporation
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software us...
Cardiac Devices·14,328 affected·Nov 30, 2023
High RiskFDA
Turncare, Inc
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Medical Devices·1,081 affected·Nov 1, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW),...
Medical Devices·10,183 affected·Oct 19, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Medical Devices·0 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Medical Devices·216 affected·Oct 10, 2023
High RiskFDA
Philips Ultrasound, Inc.
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Diagnostic Devices·7 affected·Oct 9, 2023
High RiskFDA
Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Medical Devices·141 affected·Sep 21, 2023
CriticalFDA
Asensus Surgical Inc
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catal...
Surgical Devices·21 affected·Sep 15, 2023
High RiskFDA
Ge Healthcare
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Medical Devices·329 affected·Sep 14, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides com...
Surgical Devices·12 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Surgical Devices·237 affected·Sep 12, 2023
High RiskFDA
Blue Belt Technologies, Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Medical Devices·56 affected·Sep 7, 2023
High RiskFDA
Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Medical Devices·324 affected·Sep 5, 2023
High RiskFDA
Philips North America Llc
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product C...
Medical Devices·13 affected·Aug 31, 2023
High RiskFDA
Royalvibe Health Ltd.
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, Royal...
Medical Devices·564 affected·Aug 30, 2023
High RiskFDA
Impedimed Limited
SOZO Bilateral Arm L-Dex Software
Medical Devices·354 affected·Aug 17, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; softw...
Medical Devices·20,383 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 010...
Medical Devices·67,507 affected·Aug 16, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Medical Devices·89 affected·Aug 10, 2023
High RiskFDA
Philips Healthcare
Incisive CT, software version 5.0
Medical Devices·140 affected·Aug 2, 2023
RecallFDA
Diversatek Healthcare
ZVU Functional GI Software, REF: ZVU-3
Medical Devices·20 affected·Jul 25, 2023
High RiskFDA
Stryker Corporation
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and reco...
Surgical Devices·57 affected·Jul 10, 2023
High RiskFDA
Digisonics, Inc
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Medical Devices·32 affected·Jun 26, 2023
High RiskFDA
Medtronic Neuromodulation
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medical Devices·2 affected·Jun 21, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optional...
Respiratory Devices·701 affected·Jun 15, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults an...
Respiratory Devices·2,319 affected·Jun 15, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants a...
Respiratory Devices·399 affected·Jun 15, 2023
CriticalFDA
Baxter Healthcare Corporation
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Medical Devices·19,861 affected·Jun 15, 2023
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: ...
Medical Devices·153 affected·Jun 14, 2023
High RiskFDA
Ptw-freiburg
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using Array...
Medical Devices·42 affected·Jun 7, 2023
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Medical Devices·44 affected·Jun 6, 2023
High RiskFDA
Beckman Coulter Biomedical Gmbh
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Medical Devices·15 affected·Jun 2, 2023
RecallFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Medical Devices·4 affected·May 4, 2023
CriticalFDA
Biofire Diagnostics, Llc
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Medical Devices·61,069 affected·Apr 25, 2023
High RiskFDA
Philips North America
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Medical Devices·591 affected·Apr 19, 2023
High RiskFDA
Illumina, Inc.
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Medical Devices·740 affected·Apr 5, 2023