Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 9/17/2014 Class lI: PRODUCT Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Recall Number Z-2292-2014 REASON It was discovered that during a RAD examination using Siemens Luminos...Read More
Company: Radiometer America Inc..Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data. Recall Number Z-2597-2014 REASON No reason...Read More
Company: Illumina, Inc.Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and...Read More
Company: GE Healthcare Date of Enforcement Report: 9/17/2014 Class lI: PRODUCT CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450,...Read More
Company: Ab SciexDate of Enforcement Report: 9/17/2014 Class lI: PRODUCT AB SCIEX API 3200MD” LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543. Recall Number Z-2609-2014 REASON Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!