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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 44 of 3592

Mode Product Rule Evidence excerpt
Device software or design SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system reason.device_software_design · v1.0.0 software issue
Device software or design SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system reason.device_software_design · v1.0.0 software issue
Device software or design Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. reason.device_software_design · v1.0.0 software bug
Device software or design Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f 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. reason.device_software_design · v1.0.0 software bug
Device software or design Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus. reason.device_software_design · v1.0.0 Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may
Device software or design VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. reason.device_software_design · v1.0.0 Software anomaly
Device software or design VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring. reason.device_software_design · v1.0.0 software defect
Device software or design Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only reason.device_software_design · v1.0.0 Software. Error
Device software or design VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure. reason.device_software_design · v1.0.0 software defect
Device software or design Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. reason.device_software_design · v1.0.0 software (CFA). Incorrect
Device software or design Xhibit Telemetry Receiver, Model: 96280 reason.device_software_design · v1.0.0 Software related alarm escalation defect
Device software or design DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system. reason.device_software_design · v1.0.0 software issue
Device software or design Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only reason.device_software_design · v1.0.0 Software. Error
Device software or design Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations. reason.device_software_design · v1.0.0 software (CFA). Incorrect
Device software or design VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. reason.device_software_design · v1.0.0 Software anomaly
Device software or design Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. . reason.device_software_design · v1.0.0 fault in the swivel base axis not being detected by the system software
Device software or design VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. reason.device_software_design · v1.0.0 Software anomaly
Device software or design Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area. reason.device_software_design · v1.0.0 Software anomaly
Device software or design SOMATOM Emotion 6; the intended use of computed tomography is 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 angels or spiral planes taken at different angles. reason.device_software_design · v1.0.0 Software bugs in VC20B SP0a or SP1 software versions may cause issues that could
Device software or design Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. reason.device_software_design · v1.0.0 software error
Device software or design ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 reason.device_software_design · v1.0.0 Software error VE10B -In case of a fault
Device software or design Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents. reason.device_software_design · v1.0.0 Software Anomaly
Device software or design PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 reason.device_software_design · v1.0.0 design issue
Device software or design Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards. reason.device_software_design · v1.0.0 firmware bug causes incorrect
Device software or design Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. reason.device_software_design · v1.0.0 problem was detected in the Philips IntelliSpace PAC 4.4 software

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