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
- RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- Merge LIS
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- defect in the software
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- Mode
- Device software or design
- Product
- iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version (disk batch 629774) contained a bug
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- Mode
- Device software or design
- Product
- Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate
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- Mode
- Device software or design
- Product
- Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software generates this message, it does not prevent
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- Mode
- Device software or design
- Product
- The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issues that may cause
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- Mode
- Device software or design
- Product
- TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software defect
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- Mode
- Device software or design
- Product
- The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- firmware versions, in case a Clot Detection error (error
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- Mode
- Device software or design
- Product
- RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- defect relates to firmware
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- Mode
- Device software or design
- Product
- Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- issue will occur only with MLC software
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- Mode
- Device software or design
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- MiniMed Paradigm Insulin pump, model number MMT-712
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- MiniMed Paradigm 512 Insulin pump
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software error
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- Mode
- Device software or design
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- cybersecurity vulnerabilities
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- Mode
- Device software or design
- Product
- ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate
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- Mode
- Device software or design
- Product
- Synaptive ImageDrive Clinical
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
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- Mode
- Device software or design
- Product
- Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- incorrect due to software
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- Mode
- Device software or design
- Product
- Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software design problem