Day

June 1, 2016
Company:Volcano Corporation Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of...
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Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...
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Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 6/1/2016 Class lI: PRODUCT RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. Recall Number Z-1712-2016 REASON A software issue with editing tools that use the left mouse button held down, for drawing in...
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Company: GE Medical Systems, LLC Date of Enforcement Report 6/1/2016 Class lI: PRODUCT GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Recall Number Z-1707-2016 REASON Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time...
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Company: GE Medical Systems, LLC Date of Enforcement Report 6/1/2016 Class lI: PRODUCT GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Recall Number Z-1706-2016 REASON Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time...
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Company: Elekta Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number Z-1705-2016 REASON If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to...
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