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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 27 of 3592

Mode Product Rule Evidence excerpt
Device software or design Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. reason.device_software_design · v1.0.0 software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may
Device software or design IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. reason.device_software_design · v1.0.0 software versions 7.5 and 7.7 calculation printouts and exported reports can
Device software or design IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. reason.device_software_design · v1.0.0 software versions 7.5 and 7.7 calculation printouts and exported reports can
Device software or design Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. reason.device_software_design · v1.0.0 Software defect
Device software or design Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. reason.device_software_design · v1.0.0 Software issue
Device software or design VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H reason.device_software_design · v1.0.0 design verification test failures
Device software or design Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals. reason.device_software_design · v1.0.0 Software defect
Device software or design AMSCO 400 and AMSCO C Small Steam Sterilizers reason.device_software_design · v1.0.0 software inadvertently prevents
Device software or design CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided 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 upgrade to correct potential safety issue
Device software or design VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing. reason.device_software_design · v1.0.0 Software anomaly
Device software or design DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. reason.device_software_design · v1.0.0 software issue
Device software or design iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. reason.device_software_design · v1.0.0 Software: Potentially incorrect
Device software or design TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM reason.device_software_design · v1.0.0 design verification test failures
Device software or design Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. reason.device_software_design · v1.0.0 Software issue
Device software or design Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. reason.device_software_design · v1.0.0 software VC1x software if a network problem
Device software or design Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. reason.device_software_design · v1.0.0 software produced a number of "do not route" exceptions, which may result in

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