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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 51 of 3592

Mode Product Rule Evidence excerpt
Device software or design US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082 reason.device_software_design · v1.0.0 firmware code may result in the pump not sending the expected error
Device software or design IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. reason.device_software_design · v1.0.0 Software design error
Device software or design Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body. reason.device_software_design · v1.0.0 software issue
Device software or design Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories reason.device_software_design · v1.0.0 software with operating systems with which it has not been validated or released which can
Device software or design Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. reason.device_software_design · v1.0.0 software defect
Device software or design Siemens syngo.plaza. Radiological image processing system reason.device_software_design · v1.0.0 malfunction when using syngo.plaza with software
Device software or design cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids. reason.device_software_design · v1.0.0 software malfunction
Device software or design Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082 reason.device_software_design · v1.0.0 firmware code may result in the pump not sending the expected error
Device software or design Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific) reason.device_software_design · v1.0.0 firmware code may result in the pump not sending the expected error
Device software or design GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station. reason.device_software_design · v1.0.0 software version 2.0.2 units may
Device software or design LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. reason.device_software_design · v1.0.0 Software defect
Device software or design Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 reason.device_software_design · v1.0.0 software bug
Device software or design MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system 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 issue is an error in the software
Device software or design Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time. reason.device_software_design · v1.0.0 Software anomaly
Device software or design The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. reason.device_software_design · v1.0.0 software version 2.3.6 is now longer and may sometimes fail to
Device software or design Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG). reason.device_software_design · v1.0.0 incorrect software
Device software or design Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis. reason.device_software_design · v1.0.0 software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in
Device software or design Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis reason.device_software_design · v1.0.0 software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in
Device software or design Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography. reason.device_software_design · v1.0.0 firmware problem
Device software or design Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. reason.device_software_design · v1.0.0 software error
Device software or design VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE. reason.device_software_design · v1.0.0 software issue

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