Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 10/12/2016 Class lI: PRODUCT RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) — Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Celesteion PCA-9000rV2 CT Scanner Recall Number Z-0049-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Aquilion RXL TSX-1 01 AIR, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head. Recall Number Z-0047-2017 REASON It has been found...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc. Aquilion Lightning TSX-035A CT Scanner. Recall Number Z-0046-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning...Read More

Company: Toshiba America Medical Systems, Inc Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner Recall Number Z-0048-2017 REASON It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a...Read More