Core noun
Failure mode assignments
Deterministic labels derived from preserved recall-reason text.
Indexed record set
89,789 assignments
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- Mode
- Device software or design
- Product
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect may cause an incorrect
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- Mode
- Device software or design
- Product
- Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue related to the date/time format. This connection issue
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- Mode
- Device software or design
- Product
- VITEK 2 Systems and VITEK 2 with MYLA.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issue
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- Mode
- Device software or design
- Product
- ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issue
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- Mode
- Device software or design
- Product
- Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
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- Mode
- Device software or design
- Product
- SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software malfunction
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- Mode
- Device software or design
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect may cause an incorrect
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- Mode
- Device software or design
- Product
- The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issues affecting incorrect image display, error
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- Mode
- Device software or design
- Product
- Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software would error
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- Mode
- Device software or design
- Product
- Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- firmware and the Automation software without any error
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- Mode
- Device software or design
- Product
- Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software bug
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- Mode
- Device software or design
- Product
- BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software is experiencing: 1) ES device download failure
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- Mode
- Device software or design
- Product
- STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- bug in this firmware
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- Mode
- Device software or design
- Product
- Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Firmware for the ADVIA Centaur XP/XPT Interface Module may
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- Mode
- Device software or design
- Product
- Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to
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- Mode
- Device software or design
- Product
- HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- issue in the firmware
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- Mode
- Device software or design
- Product
- HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- firmware and the Automation software without any error
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- Mode
- Device software or design
- Product
- DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- issue in the firmware
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- Mode
- Device software or design
- Product
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error