February 8, 2008
Company: Vital Images, Inc., Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Vital Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze...
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Company: Varian Medical Systems, Inc., Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models, Recall # Z-0554-2008 REASON Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets...
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Recipient: Spinal, USAProduct:Slimplicity Anterior Cervical Plate System, the Spinal USA Cement Restrictor and the Spinal USA Vertebral Body Replacement (VBR) System Date:12/7/2007 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture,...
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Company: Cyberonics, Inc., , Date of Enforcement Report 2/6/2008 Class:lll PRODUCT Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher, Recall # 0568-2008 REASON Screen Freezes– The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and...
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Company: Baxter Healthcare Renal Division Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Baxter RenalSoft v.2.0 Patient Management Software Suite – HD Module; clinical data management software, Recall # Z-0527-2008; b) Baxter Renal Software Suite v.3.0 and v.3.1 – Renal Link HD Module; clinical data management software; Recall # Z-0528-2008 REASON Pre-Treatment/Post-Treatment Report errors: 1) The...
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