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
Heidelberg Engineering
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Medical Devices·382 affected·Dec 8, 2017
High RiskFDA
Datex-ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanica...
Respiratory Devices·349 affected·Dec 8, 2017
High RiskFDA
Hitachi Ltd., Medical System Operations Group
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions...
Medical Devices·1 affected·Dec 8, 2017
High RiskFDA
Intel-ge Care Innovations Llc
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool...
Medical Devices·1,302 affected·Dec 6, 2017
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro...
Diabetes Devices·14,340 affected·Dec 4, 2017
High RiskFDA
Cellavision Ab
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Produc...
Medical Devices·224 affected·Dec 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices·58 affected·Nov 22, 2017
High RiskFDA
Covidien Llc
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Vent...
Respiratory Devices·15,885 affected·Nov 21, 2017
High RiskFDA
Oculus Optikgeraete Gmbh
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikge...
Medical Implants·83 affected·Nov 21, 2017
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (Ray...
Medical Devices·744 affected·Nov 20, 2017
High RiskFDA
Phadia Ab
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and El...
Diagnostic Devices·2,307 affected·Nov 20, 2017
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate ...
Medical Devices·8 affected·Nov 17, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-H...
Medical Implants·560 affected·Nov 15, 2017
High RiskFDA
Carl Zeiss Metrology Inc
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Medical Devices·13 affected·Nov 14, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Diagnostic Devices·1,385 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Diagnostic Devices·134 affected·Nov 8, 2017
High RiskFDA
Med Tec Inc
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1...
Medical Devices·5 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Diagnostic Devices·238 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body ...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body o...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Normand Informatique
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management System...
Medical Devices·34 affected·Oct 16, 2017
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anest...
Respiratory Devices·110 affected·Oct 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
Medical Devices·1,801 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core computed tomography x-ray system
Medical Devices·0 affected·Oct 6, 2017
High RiskFDA
Edwards Lifesciences, Llc
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart...
Cardiac Devices·198 affected·Oct 2, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL...
Diagnostic Devices·268 affected·Oct 2, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, ...
Surgical Devices·2,012 affected·Aug 31, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient...
Surgical Devices·2,012 affected·Aug 31, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, ...
Surgical Devices·2,012 affected·Aug 31, 2017
High RiskFDA
St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is i...
Medical Implants·164,366 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI...
Medical Implants·529,912 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transm...
Medical Implants·495,011 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a porta...
Medical Implants·10,453 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a sin...
Medical Implants·102,684 affected·Aug 28, 2017
High RiskFDA
Biomerieux Inc
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, softwar...
Medical Implants·11,703 affected·Aug 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembe...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pem...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Diagnostic Devices·213 affected·Aug 21, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 ...
Medical Devices·47 affected·Aug 18, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·98 affected·Aug 14, 2017
High RiskFDA
Nucletron Bv
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning ...
Medical Devices·89 affected·Aug 10, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·11 affected·Aug 7, 2017
High RiskFDA
Mako Surgical Corporation
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist th...
Medical Devices·349 affected·Aug 7, 2017
High RiskFDA
Mako Surgical Corporation
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in ...
Medical Devices·291 affected·Aug 7, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a sof...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digit...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s ...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Medical Devices·399 affected·Jul 28, 2017