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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 52 of 3592

Mode Product Rule Evidence excerpt
Device software or design PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 reason.device_software_design · v1.0.0 design issue
Device software or design Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files. reason.device_software_design · v1.0.0 software bug
Device software or design Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K 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-RAD 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 Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC 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 EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. reason.device_software_design · v1.0.0 software version 1.0 and 1.0.1. Using the International System Date Format may result in
Device software or design PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 reason.device_software_design · v1.0.0 design issue
Device software or design Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological reason.device_software_design · v1.0.0 software bug
Device software or design Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. reason.device_software_design · v1.0.0 software bug
Device software or design PRONOVA SUTURE BLUE 122CM M1.5, D10189 reason.device_software_design · v1.0.0 design issue
Device software or design Dimension Vista 500, model no. 10284473 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 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 reason.device_software_design · v1.0.0 design issue
Device software or design Kaguya 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 Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 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 enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. reason.device_software_design · v1.0.0 Software Anomaly
Device software or design PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 reason.device_software_design · v1.0.0 design issue
Device software or design PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 reason.device_software_design · v1.0.0 design issue
Device software or design PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 reason.device_software_design · v1.0.0 design issue
Device software or design PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 reason.device_software_design · v1.0.0 design issue
Device software or design Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. reason.device_software_design · v1.0.0 software defect
Device software or design Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. reason.device_software_design · v1.0.0 software defect
Device software or design Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay reason.device_software_design · v1.0.0 programming error
Device software or design Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices. reason.device_software_design · v1.0.0 software malfunction
Device software or design Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. reason.device_software_design · v1.0.0 software defect
Device software or design Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion. reason.device_software_design · v1.0.0 software defect

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