Core noun
Failure mode assignments
Deterministic labels derived from preserved recall-reason text.
Indexed record set
89,789 assignments
-
- Mode
- Device software or design
- Product
- Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software bug
-
- Mode
- Device software or design
- Product
- Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- failure alarm condition. INOmax DSIR with software
-
- Mode
- Device software or design
- Product
- SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- error message (code=2). Also, the SurgiCounter scanner software
-
- Mode
- Device software or design
- Product
- ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software anomaly
-
- Mode
- Device software or design
- Product
- iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
-
- Mode
- Device software or design
- Product
- Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
-
- Mode
- Device software or design
- Product
- NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
-
- Mode
- Device software or design
- Product
- AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 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.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software where under certain conditions a user can
-
- Mode
- Device software or design
- Product
- The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect may cause incorrect
-
- Mode
- Device software or design
- Product
- Brilliance 64 Computed Tomography X-ray system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software (versions preceding 4.1.2) without buying the helical perfusion license key could
-
- Mode
- Device software or design
- Product
- VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software timing anomaly
-
- Mode
- Device software or design
- Product
- Brilliance iCT SP 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
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
-
- Mode
- Device software or design
- Product
- Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
-
- Mode
- Device software or design
- Product
- Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software containing a programming error (bug
-
- Mode
- Device software or design
- Product
- Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defects which could
-
- Mode
- Device software or design
- Product
- Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
-
- Mode
- Device software or design
- Product
- SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software update that provides bug
-
- Mode
- Device software or design
- Product
- Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software Error
-
- Mode
- Device software or design
- Product
- VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, 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 Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software anomaly
-
- Mode
- Device software or design
- Product
- MEVION S250, used for proton radiation therapy.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software defect that causes an incorrect
-
- Mode
- Device software or design
- Product
- Sedecal SA Mobile Diagnost w DR x-ray system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
-
- Mode
- Device software or design
- Product
- Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- malfunction when using system operating with software
-
- Mode
- Device software or design
- Product
- Ingenuity Core 128 Computed Tomography X-ray system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software (versions preceding 4.1.2) without buying the helical perfusion license key could
-
- Mode
- Device software or design
- Product
- Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software Ver: VB10C: Printouts may be printed in incorrect
-
- Mode
- Device software or design
- Product
- Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect