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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 54 of 3592

Mode Product Rule Evidence excerpt
Device software or design ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery reason.device_software_design · v1.0.0 software coding error
Device software or design iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. reason.device_software_design · v1.0.0 bug in the software prevents the iGUIDE software
Device software or design PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 reason.device_software_design · v1.0.0 design issue
Device software or design CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask. reason.device_software_design · v1.0.0 design change, customers may not be aware of the incompatib
Device software or design PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 reason.device_software_design · v1.0.0 design issue
Device software or design PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 reason.device_software_design · v1.0.0 design issue
Device software or design PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 reason.device_software_design · v1.0.0 design issue
Device software or design PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 reason.device_software_design · v1.0.0 design issue
Device software or design JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information reason.device_software_design · v1.0.0 Software issue
Device software or design Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body reason.device_software_design · v1.0.0 Software error
Device software or design SOMATOM Definition AS System, x-ray, tomography, computed 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 software and firmware bug
Device software or design BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT) reason.device_software_design · v1.0.0 software defect
Device software or design VITEK¿ 2 Systems Software Version 9.01 Update Kit. reason.device_software_design · v1.0.0 Software Version 9.01 software may display incorrect
Device software or design Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. reason.device_software_design · v1.0.0 issue with Dimension Vista software
Device software or design Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS 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; UPG MX-O SVR 15K 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 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS 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 ADD 100K E/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; UPG MX-RAD SVR 75K 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 Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup 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; UPG MX-O SVR 75K 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 Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. reason.device_software_design · v1.0.0 Software error. Incorrect
Device software or design Brilliance CT 16 Power, Model number 728240 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 Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress. reason.device_software_design · v1.0.0 firmware problem
Device software or design PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 reason.device_software_design · v1.0.0 design issue

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