Company: Smith & NephewDate of Enforcement Report 12/22/2010 Class ll: PRODUCT Smith & Nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation....Read More

Company: SonoSite.Date of Enforcement Report 12/22/2010 Class lll: PRODUCT The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system. Part code: P11111-35. Recall # Z-0478-2011 REASON Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the...Read More

Company: SCC Soft Computer.Date of Enforcement Report 12/22/2010 Class l: PRODUCT SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel. Recall # Z-0344-2011...Read More

Company: SCC Soft Computer..Date of Enforcement Report 12/22/2010 Class ll: PRODUCT SoftLab GUI Version 4.0.1.0 – 4.0.1.16, 4.0.2.0 – 4.0.2.10, 4.0.3.0 – 4.0.3.13, and 4.0.4.0 – 4.0.4.5. Manufacture/Distribution Dates: 4.0.1.0 – 08/06/04, 4.0.1.4 – 10/18/04, 4.0.1.5 – 01/18/04, 4.0.1.6 – 12/15/04, 4.0.1.7 – 01/10/05, 4.0.1.8 – 03/29/05, 4.0.1.9 – 05/06/05, 4.0.1.13 – 01/25/06, 4.0.1.14 –...Read More

Company: SCC Soft Computer..Date of Enforcement Report 12/22/2010 Class ll: PRODUCT SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. 23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and...Read More

Company: GE Medical Systems.Date of Enforcement Report 12/22/2010 Class ll: PRODUCT Signa Excite” 1.5 T Magnetic Resonance Systems. Recall # Z-0462-2011p> REASON Signa? MR Excite” 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip...Read More

Company: Philips Medical SystemsDate of Enforcement Report 12/22/2010 Class ll: PRODUCT Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or...Read More

Company: GE Healthcare, LLC.Date of Enforcement Report 12/22/2010 Class ll: PRODUCT 1) GE LightSpeed VCT Scanner System, models: a) 5212920-300, b) 5212920-310, c) 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce...Read More