Company: Medtronic Navigation, Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Recall Number Z-1956-2013 REASON Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and...Read More

Company: Veridex, LLC Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT 1. CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as...Read More

Company: Carestream Health Inc. Date of Enforcement Report: 8/21/2013 Class ll: PRODUCT Carestream DRX Evolution System, X-ray system — The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Recall Number Z-1877-2013 REASON To a potential for an x-ray exposure technique change. RECALLING FIRM/MANUFACTURER Carestream...Read More