Company:Orthosensor Date of Enforcement Report 10/31/12 Class ll: PRODUCT ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***” Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.Recall Number Z-0122-2013 REASON Ortho sensor in Sunrise, FL...Read More

Company:Elekta, Inc. Date of Enforcement Report 10/31/12 Class ll: PRODUCT Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. Recall Number Z-0118-2013 REASON During the planning process the beam weights can be changed by the customers. When the...Read More

Company: GE Healthcare, LLC Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of...Read More

Company:GE Healthcare LLC. Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. Recall Number Z-0125-2013 REASON GE Healthcare has recently...Read More