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Recall Observatory FDA recall evidence

Core noun

Failure mode assignments

Deterministic labels derived from preserved recall-reason text.

Indexed record set

89,789 assignments

Page 53 of 3592

Mode Product Rule Evidence excerpt
Device software or design Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump. reason.device_software_design · v1.0.0 software malfunction
Device software or design MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712. reason.device_software_design · v1.0.0 software anomaly
Device software or design Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. reason.device_software_design · v1.0.0 software issue
Device software or design Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 reason.device_software_design · v1.0.0 software bug
Device software or design MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. reason.device_software_design · v1.0.0 software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to
Device software or design Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 Software defect
Device software or design Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 Software defect
Device software or design SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. reason.device_software_design · v1.0.0 Software bugs in VC20B SP0a or SP1 software versions may cause issues that could
Device software or design SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles reason.device_software_design · v1.0.0 Software update that provides software and firmware bug
Device software or design VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. reason.device_software_design · v1.0.0 Software Anomaly: the firm has identified an anomaly
Device software or design Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can
Device software or design Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer reason.device_software_design · v1.0.0 Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in
Device software or design Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. reason.device_software_design · v1.0.0 software error
Device software or design Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. reason.device_software_design · v1.0.0 software issue
Device software or design OEC UroView 2800, fluoroscopic x-ray system reason.device_software_design · v1.0.0 firmware issue
Device software or design Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can
Device software or design Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can
Device software or design ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. reason.device_software_design · v1.0.0 Software issue
Device software or design Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal. reason.device_software_design · v1.0.0 software error
Device software or design A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 reason.device_software_design · v1.0.0 software bug
Device software or design enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD reason.device_software_design · v1.0.0 Software anomaly
Device software or design Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost. reason.device_software_design · v1.0.0 incorrect firmware
Device software or design SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system reason.device_software_design · v1.0.0 error between the firmware and the software
Device software or design Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 reason.device_software_design · v1.0.0 Software defect

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