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
Optovue, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is sui...
Diagnostic Devices·326 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomo...
Medical Devices·326 affected·Jul 27, 2017
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device ...
Respiratory Devices·2,875 affected·Jul 14, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for t...
Diagnostic Devices·9,234 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus...
Diagnostic Devices·1,866 affected·Jul 12, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Medical Devices·429 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Medical Devices·367 affected·Jun 30, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to dril...
Medical Implants·84 affected·Jun 26, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integratio...
Medical Devices·18 affected·Jun 13, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 /...
Diabetes Devices·1,134 affected·Jun 8, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN nu...
Diabetes Devices·67,040 affected·Jun 8, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge OrthoPACS software.
Medical Devices·98 affected·May 24, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication ...
Medical Devices·2 affected·May 22, 2017
High RiskFDA
Neusoft Medical Systems Co., Ltd.
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or...
Medical Devices·234 affected·May 19, 2017
High RiskFDA
Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medical Devices·108 affected·May 10, 2017
High RiskFDA
Ortho-clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2
Medical Devices·16 affected·Apr 26, 2017
High RiskFDA
Cardiotek Bv
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, di...
Cardiac Devices·8 affected·Apr 13, 2017
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system test...
Medical Devices·159 affected·Apr 10, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for...
Diagnostic Devices·188 affected·Apr 3, 2017
CriticalFDA
Thoratec Corporation
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic...
Cardiac Devices·24,077 affected·Mar 30, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer...
Cardiac Devices·2,045 affected·Mar 30, 2017
CriticalFDA
Thoratec Corporation
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic...
Cardiac Devices·24,077 affected·Mar 30, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee, Angiographic x-ray system
Medical Devices·3 affected·Mar 28, 2017
High RiskFDA
Nexstim Plc
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for no...
Surgical Devices·11 affected·Mar 14, 2017
High RiskFDA
Nexstim Plc
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. ...
Surgical Devices·21 affected·Mar 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, comm...
Medical Devices·104 affected·Mar 6, 2017
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intend...
Medical Devices·1 affected·Mar 2, 2017
High RiskFDA
Zimmer Biomet, Inc.
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be u...
Surgical Devices·1 affected·Feb 27, 2017
High RiskFDA
Liebel-flarsheim Company Llc
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic proc...
Diagnostic Devices·28 affected·Feb 27, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) inten...
Medical Devices·13 affected·Feb 20, 2017
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (C...
Medical Devices·3,440 affected·Feb 15, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Avant-garde
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Medical Devices·80 affected·Feb 14, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge LIS
Medical Devices·47 affected·Jan 23, 2017
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and ana...
Medical Devices·741 affected·Jan 18, 2017
High RiskFDA
Med-hot Thermal Imaging, Inc.
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagn...
Diagnostic Devices·12 affected·Jan 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mam...
Medical Devices·55 affected·Jan 11, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, picture archiving and communications system.
Medical Devices·62 affected·Jan 11, 2017
High RiskFDA
Haag-streit Usa Inc
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Medical Devices·163 affected·Jan 5, 2017
High RiskFDA
Hospira Inc., A Pfizer Company
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as pare...
Medical Devices·62,847 affected·Dec 30, 2016
High RiskFDA
Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan ra...
Medical Devices·433 affected·Dec 23, 2016
High RiskFDA
Tosoh Smd Inc
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware bet...
Medical Devices·34 affected·Dec 22, 2016
High RiskFDA
Agfa Healthcare Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to docume...
Medical Devices·10 affected·Dec 22, 2016
High RiskFDA
Agfa Healthcare Corp.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Medical Devices·221 affected·Dec 21, 2016
High RiskFDA
Dicom Grid Inc
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnosti...
Diagnostic Devices·209 affected·Dec 16, 2016
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and...
Medical Devices·6 affected·Dec 13, 2016