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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 34 of 3592

Mode Product Rule Evidence excerpt
Device software or design MOMENTUM X4 CRT-D, Model G138, Sterile. reason.device_software_design · v1.0.0 incorrect firmware
Device software or design GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. reason.device_software_design · v1.0.0 software, incorrect
Device software or design RESONATE X4 CRT-D, Model G447, Sterile. reason.device_software_design · v1.0.0 incorrect firmware
Device software or design Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. reason.device_software_design · v1.0.0 software error
Device software or design Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. reason.device_software_design · v1.0.0 issue has been identified for customers using software
Device software or design MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated reason.device_software_design · v1.0.0 software will
Device software or design Ingenuity Core 728321 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories reason.device_software_design · v1.0.0 Software error
Device software or design Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps. reason.device_software_design · v1.0.0 software, in combination with the SapphirePlus 13.1x infusion pump, may result in
Device software or design VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: 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
Device software or design AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use. reason.device_software_design · v1.0.0 software where under certain conditions a user can
Device software or design Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument reason.device_software_design · v1.0.0 software anomalies
Device software or design Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. reason.device_software_design · v1.0.0 software security issue
Device software or design Ingenuity Core Computed Tomography X-ray system reason.device_software_design · v1.0.0 software (versions preceding 4.1.2) without buying the helical perfusion license key could
Device software or design CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. reason.device_software_design · v1.0.0 issue with the software
Device software or design MEVION S250 Product Usage: Proton Radiation Therapy System reason.device_software_design · v1.0.0 Software defect:2D projection of contours in Verity. The defect
Device software or design Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. reason.device_software_design · v1.0.0 Software anomaly
Device software or design DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. reason.device_software_design · v1.0.0 software issue
Device software or design Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option reason.device_software_design · v1.0.0 issue occurs when the software
Device software or design Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. reason.device_software_design · v1.0.0 Software bugs in these SOMATOM systems could possibly cause
Device software or design Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. reason.device_software_design · v1.0.0 software are changing after saving a plan with a measurement result, which may result in
Device software or design Ingenuity Core 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 error

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