Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 1/29/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the algorithm...Read More

Company: Elekta inc. Date of Enforcement Report:1/29/2014 Class lI: PRODUCT XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose...Read More