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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 10 of 3592

Mode Product Rule Evidence excerpt
Device software or design Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C reason.device_software_design · v1.0.0 firmware version 6.1.2 can
Device software or design Zenition 70, Model #718133 reason.device_software_design · v1.0.0 firmware issue
Device software or design Veradius Unity, Model #718132 reason.device_software_design · v1.0.0 firmware issue
Device software or design Alinity m System, Part No. 08N53-002 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids. reason.device_software_design · v1.0.0 software error
Device software or design Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. reason.device_software_design · v1.0.0 software anomaly
Device software or design Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system reason.device_software_design · v1.0.0 software will result in
Device software or design ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures. reason.device_software_design · v1.0.0 software version VE20B. Potential issues include System error
Device software or design Merge Hemo, Software packages 10.2, 10.3, and 10.4 reason.device_software_design · v1.0.0 issue affecting the software
Device software or design 728333 Spectral CT 7500 -Computed Tomography X-ray system reason.device_software_design · v1.0.0 software will result in
Device software or design TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420579 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design Change Healthcare Enterprise Viewer reason.device_software_design · v1.0.0 software defect
Device software or design Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400 reason.device_software_design · v1.0.0 Software 2.51 and Lower with Installed CO2 Measurement Option, may result in
Device software or design EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 reason.device_software_design · v1.0.0 software issue
Device software or design Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 reason.device_software_design · v1.0.0 software crash. This would result in
Device software or design Incisive CT, software version 5.0 reason.device_software_design · v1.0.0 software issues with compliance concerns to Subchapter J: Issue
Device software or design TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. reason.device_software_design · v1.0.0 Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate
Device software or design Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. reason.device_software_design · v1.0.0 issue (bug) has been identified with the interface and image software
Device software or design MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. reason.device_software_design · v1.0.0 Software anomaly
Device software or design CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. reason.device_software_design · v1.0.0 Software error
Device software or design Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications. reason.device_software_design · v1.0.0 software version 4.0.0., 4.0.1, and 4.0.2 has an error
Device software or design Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. reason.device_software_design · v1.0.0 Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can
Device software or design Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D reason.device_software_design · v1.0.0 software to help reduce the incidence of Error
Device software or design MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. reason.device_software_design · v1.0.0 software for the celling arm of the X-Ray System . This software issue

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