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
Medtronic Xomed, Inc.
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Medical Devices·29 affected·May 3, 2022
High RiskFDA
Medtronic Xomed, Inc.
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Medical Devices·18 affected·May 3, 2022
High RiskFDA
Daavlin Distributing Company
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305...
Medical Devices·216 affected·Apr 26, 2022
High RiskFDA
Dain Technology, Inc. (subsidiary Of Soundable Health, Inc.)
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Medical Devices·41 affected·Apr 21, 2022
CriticalFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500...
Medical Devices·65,093 affected·Apr 18, 2022
High RiskFDA
Baxter Healthcare Corporation
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and eme...
Medical Devices·1,414 affected·Apr 13, 2022
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR...
Medical Devices·3,944 affected·Apr 12, 2022
High RiskFDA
Philips North America Llc
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images...
Medical Devices·330 affected·Mar 29, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Medical Devices·68 affected·Mar 11, 2022
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Medical Devices·15 affected·Mar 9, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SO...
Medical Devices·547 affected·Mar 7, 2022
High RiskFDA
Draegar Medical Systems, Inc.
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry ...
Medical Devices·1,950 affected·Mar 4, 2022
High RiskFDA
Medtronic Neuromodulation
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) T...
Medical Devices·1,005 affected·Feb 28, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnos...
Diagnostic Devices·35 affected·Feb 25, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diag...
Diagnostic Devices·94 affected·Feb 25, 2022
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1
Diagnostic Devices·11 affected·Feb 25, 2022
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 I...
Medical Devices·205 affected·Feb 25, 2022
High RiskFDA
Draeger Medical, Inc.
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog N...
Respiratory Devices·24,337 affected·Feb 14, 2022
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 ...
Respiratory Devices·13,687 affected·Feb 14, 2022
High RiskFDA
Abbott Laboratories, Inc
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro di...
Diagnostic Devices·306 affected·Feb 3, 2022
High RiskFDA
Philips Healthcare
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Medical Implants·42 affected·Feb 2, 2022
High RiskFDA
Philips North America Llc
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, ...
Medical Implants·338 affected·Feb 2, 2022
High RiskFDA
Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Medical Devices·3,216 affected·Jan 19, 2022
High RiskFDA
Stryker Corporation
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and...
Medical Devices·11,955 affected·Jan 14, 2022
High RiskFDA
Diagnos Inc
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Medical Devices·1 affected·Jan 11, 2022
High RiskFDA
Philips North America Llc
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5....
Medical Devices·36 affected·Jan 3, 2022
High RiskFDA
Biomerieux Inc
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. I...
Medical Devices·462 affected·Dec 20, 2021
High RiskFDA
Konica Minolta Healthcare Americas, Inc.
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for me...
Diagnostic Devices·30 affected·Dec 3, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50, Model #718096
Medical Devices·16 affected·Dec 2, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Veradius Unity, Model #718132
Medical Devices·12 affected·Dec 2, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo,...
Cardiac Devices·1,047 affected·Nov 23, 2021
High RiskFDA
Haag-streit Usa Inc
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Medical Devices·3 affected·Nov 3, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedu...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·3 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional proced...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices·38 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices·0 affected·Oct 14, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Diagnostic Devices·12 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Diagnostic Devices·72 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Diagnostic Devices·23 affected·Oct 12, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable c...
Medical Implants·18,715 affected·Oct 12, 2021
High RiskFDA
Baxter Healthcare Corporation
Hemodialysis Delivery System, Software Version 2.x.
Medical Devices·4,248 affected·Sep 29, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 7...
Medical Devices·428 affected·Sep 24, 2021
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) u...
Respiratory Devices·2,169 affected·Sep 10, 2021