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
- 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
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- Mode
- Device software or design
- Product
- Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software v1.23.2 and lower-may
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- Mode
- Device software or design
- Product
- Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- defect where the error couch motion signal of couch firmware
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- Mode
- Device software or design
- Product
- Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- anomaly in Medfusion 4000 Syringe Pump Firmware
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- Mode
- Device software or design
- Product
- Baxter Exactamix Pro 2400, REF EXM24DY
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- error was identified in software
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- Mode
- Device software or design
- Product
- WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
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- Mode
- Device software or design
- Product
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
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- Mode
- Device software or design
- Product
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software has anomalies
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- Mode
- Device software or design
- Product
- Stryker Blueprint Software, Catalog #BPUE001.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software bug
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- Mode
- Device software or design
- Product
- VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version, the user could
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- Mode
- Device software or design
- Product
- Baxter Exactamix Pro 1200, REF EXM12DY
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- error was identified in software
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- Mode
- Device software or design
- Product
- Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issue
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- Mode
- Device software or design
- Product
- epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software problem
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- Mode
- Device software or design
- Product
- VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version, the user could
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- Mode
- Device software or design
- Product
- V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- failure because after recalibration, the sensors stayed in the software
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- Mode
- Device software or design
- Product
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software error
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- Mode
- Device software or design
- Product
- HAMILTON C1 Ventilator REF 161001 1610010 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
- Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerability
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- Mode
- Device software or design
- Product
- Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
- 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
- HAMILTON-C6, REF: 160021
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
- 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
- RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software to malfunction
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- Mode
- Device software or design
- Product
- DigitalDiagnost C90, Model No. 712034 and 712035
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software login in issue