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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 50 of 3592

Mode Product Rule Evidence excerpt
Device software or design Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. reason.device_software_design · v1.0.0 Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could
Device software or design Ingenuity Core 128 Computed Tomography X-ray systems is 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 defect
Device software or design CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. reason.device_software_design · v1.0.0 Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may
Device software or design Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. reason.device_software_design · v1.0.0 software anomaly
Device software or design Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. reason.device_software_design · v1.0.0 software issue
Device software or design PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 reason.device_software_design · v1.0.0 design issue
Device software or design EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag. reason.device_software_design · v1.0.0 software. It could result in the original UI remaining in the tube which could
Device software or design PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 reason.device_software_design · v1.0.0 design issue
Device software or design TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. reason.device_software_design · v1.0.0 problem of the X-ray output control software
Device software or design Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. reason.device_software_design · v1.0.0 software problem
Device software or design Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. reason.device_software_design · v1.0.0 software problem
Device software or design Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, reason.device_software_design · v1.0.0 Software error
Device software or design Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. reason.device_software_design · v1.0.0 software problem
Device software or design Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment. reason.device_software_design · v1.0.0 software anomaly
Device software or design Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner 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 taken at different angles and planes. reason.device_software_design · v1.0.0 software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may
Device software or design Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. reason.device_software_design · v1.0.0 software error which may lead to incorrect
Device software or design Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool. reason.device_software_design · v1.0.0 defect in software
Device software or design Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY reason.device_software_design · v1.0.0 software anomaly
Device software or design Brilliance 16, Model number 728246 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. reason.device_software_design · v1.0.0 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can
Device software or design Infinite 200 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 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards. reason.device_software_design · v1.0.0 Incorrect lumi firmware
Device software or design MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. 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 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 reason.device_software_design · v1.0.0 software bug
Device software or design Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride. reason.device_software_design · v1.0.0 software error
Device software or design AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. reason.device_software_design · v1.0.0 software on Automated PD System cyclers which can cause
Device software or design PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. reason.device_software_design · v1.0.0 anomaly in the device software

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