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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 35 of 3592

Mode Product Rule Evidence excerpt
Device software or design Ingenuity Core 128 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 reason.device_software_design · v1.0.0 software error
Device software or design da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. reason.device_software_design · v1.0.0 fault for the Xi Stapler with Xi System P4 version software
Device software or design Segmental fluted stem, 18x250mm bwd, Sterile, reason.device_software_design · v1.0.0 design verification test failures
Device software or design BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN reason.device_software_design · v1.0.0 software generic volume measurement (HxWxLxl) function the user may
Device software or design R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG reason.device_software_design · v1.0.0 design verification test failures
Device software or design GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes. reason.device_software_design · v1.0.0 software that may
Device software or design Segmental malefemale taper, 200mm, 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 Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively. reason.device_software_design · v1.0.0 Software defect
Device software or design Fem IM Nail 14mmdx50cm right, 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 SOMATOM Definition Flash; 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. reason.device_software_design · v1.0.0 software bug
Device software or design Fem IM Nail 15mmdx46cm, 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 SOMATOM Definition Edge; 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. reason.device_software_design · v1.0.0 software bug
Device software or design RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. reason.device_software_design · v1.0.0 software issue
Device software or design Segmental fluted stem, 16x250mm 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 Segmental fluted stem, 18x190mm str, 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 Segmental fluted stem, 17x190mm str, 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 Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images. reason.device_software_design · v1.0.0 Incorrect values for the volume calculation. Software
Device software or design VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. reason.device_software_design · v1.0.0 software timing anomaly
Device software or design Brilliance iCT 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 reason.device_software_design · v1.0.0 software error
Device software or design NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. reason.device_software_design · v1.0.0 software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to
Device software or design Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body reason.device_software_design · v1.0.0 software issue
Device software or design AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 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. reason.device_software_design · v1.0.0 software where under certain conditions a user can
Device software or design MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. reason.device_software_design · v1.0.0 software anomaly
Device software or design Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories reason.device_software_design · v1.0.0 Software error
Device software or design Ingenuity Core 128 728323 reason.device_software_design · v1.0.0 Software error

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