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
Nova Biomedical Corporation
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for nea...
Diabetes Devices·1,615 affected·Nov 20, 2024
High RiskFDA
Mint Medical Gmbh
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Medical Devices·65 affected·Nov 15, 2024
High RiskFDA
Mint Medical Gmbh
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Medical Devices·18 affected·Nov 15, 2024
High RiskFDA
Securitas Healthcare Llc
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver App...
Medical Devices·111 affected·Nov 1, 2024
High RiskFDA
Hermes Medical Solutions Ab
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Medical Devices·778 affected·Oct 31, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software V...
Medical Devices·92 affected·Oct 29, 2024
CriticalFDA
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Medical Devices·455 affected·Oct 15, 2024
CriticalFDA
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Medical Devices·1,492 affected·Oct 15, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Medical Devices·8 affected·Oct 2, 2024
RecallFDA
Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implante...
Medical Implants·130 affected·Oct 1, 2024
RecallFDA
Zyno Medical Llc
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provid...
Medical Devices·100 affected·Sep 30, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 So...
Surgical Devices·1,749 affected·Sep 18, 2024
High RiskFDA
Topcon Medical Systems, Inc.
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digita...
Diagnostic Devices·3,144 affected·Sep 17, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: O...
Medical Devices·738 affected·Sep 13, 2024
CriticalFDA
Zyno Medical Llc
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.0...
Medical Devices·34,994 affected·Sep 13, 2024
High RiskFDA
Agfa Healthcare Nv
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-...
Diagnostic Devices·801 affected·Sep 6, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive dis...
Cardiac Devices·6 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive displ...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provid...
Cardiac Devices·9 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide p...
Cardiac Devices·161 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display ...
Cardiac Devices·2 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to pro...
Cardiac Devices·58 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive dis...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive displ...
Cardiac Devices·1 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·92 affected·Sep 5, 2024
High RiskFDA
Wingderm Electro-optics Ltd.
Non-ablative Fractional Laser Systems, Model: WFB-01
Medical Devices·0 affected·Aug 23, 2024
High RiskFDA
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is in...
Surgical Devices·1,801 affected·Aug 22, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic...
Diagnostic Devices·7,022 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: ...
Diagnostic Devices·321 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Diagnostic Devices·1,990 affected·Aug 15, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy E...
Medical Devices·90,910 affected·Jul 16, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Respiratory Devices·90,910 affected·Jul 16, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in ...
Diagnostic Devices·3,011 affected·Jul 15, 2024
High RiskFDA
Medtronic Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 20...
Medical Devices·18,788 affected·Jul 11, 2024
High RiskFDA
Beckman Coulter Mishima K.k.
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combinatio...
Diagnostic Devices·24 affected·Jul 10, 2024
High RiskFDA
Carefusion 303, Inc.
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Medical Devices·0 affected·Jul 9, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions...
Medical Devices·35 affected·Jul 8, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by heal...
Medical Devices·18 affected·Jun 28, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by heal...
Medical Devices·4 affected·Jun 28, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Medical Devices·61 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
Medical Devices·1 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
Medical Devices·4 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Medical Devices·84 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
Medical Devices·5 affected·Jun 24, 2024