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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 25 of 3592

Mode Product Rule Evidence excerpt
Device software or design Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. . reason.device_software_design · v1.0.0 design incompatibility
Device software or design i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) reason.device_software_design · v1.0.0 software version 2.8: (1) Location, operator, stored patient lists will
Device software or design A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations. reason.device_software_design · v1.0.0 software issue
Device software or design Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories. reason.device_software_design · v1.0.0 Software issues including: Software errors that may result in
Device software or design Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. reason.device_software_design · v1.0.0 software anomaly
Device software or design VIDAS 3 software v. 1.1.4 reason.device_software_design · v1.0.0 software version 1.2, some anomalies
Device software or design Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. . reason.device_software_design · v1.0.0 design incompatibility
Device software or design SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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 update that provides bug
Device software or design SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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 update that provides bug
Device software or design Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. reason.device_software_design · v1.0.0 software responsible for starting scheduled AutoQC measurements (scheduler) will
Device software or design iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. reason.device_software_design · v1.0.0 Software displayed incorrect
Device software or design Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate reason.device_software_design · v1.0.0 software issue
Device software or design RESONATE EL ICD DR, Model D433, Sterile. reason.device_software_design · v1.0.0 incorrect firmware
Device software or design Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel. reason.device_software_design · v1.0.0 Incorrect source step size may occur in the software
Device software or design Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility

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