Company: Varian Medical Systems, Inc.Date of Enforcement Report: 9/1/04 Class: II PRODUCT Varian Mdical device and software systems. Version Numbers 6.2.27 and 6.2.35, 510k number K001643. Recall # Z-1314-04. REASON A malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters...Read More

Company: The Contact Lens Store, Inc.Date of Enforcement Report: 9/1/04 Class: II PRODUCT Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee,...Read More