Day

February 13, 2019
Company: GE Healthcare, LLC Date of Enforcement Report: 2/1/2019 Class II PRODUCT GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II: PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II: PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II: PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Becton, Dickinson and Company, BD Biosciences Date of Enforcement Report: 2/1/2019 Class III: PRODUCT BD FACSLyric(TM) 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric(TM) is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell...
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Company: Radiometer America Inc Date of Enforcement Report: 2/5/2019 Class II: PRODUCT Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. Recall Number: Z-0801-2019 REASON From three incidents in Denmark...
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Came across this website that has some very detailed “commandments” for software development at their company.  A surprisingly lengthy list of dos and don’ts related to coding, testing, designing, estimating, and managing the software lifecycle.  Does your company have anything written?  I often find that each company has some “lore” – some practices that characterize...
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