Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. Recall Number Z-2563-2014 REASON It has been internally found that if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that...Read More

Company: Elekta Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Focal Sim Product Usage: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be able to perform CT simulations and forward their information to the RTP System for dose calculation....Read More

Company: Elekta Inc.Date of Enforcement Report: 9/10/2014 Class lI: PRODUCT Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given...Read More