Company: Toshiba American Medical Systems Inc.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Celesteion PCA-9000A/2 PET/CT System Recall Number Z-0005-2016 REASON It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc, Tustin,...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. Recall Number Z-0107-2016 REASON Software and firmware bugs RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/18/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0020-2016 REASON software bug issues for...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0019-2016 REASON software bug issues for...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0021-2016 REASON software bug issues for...Read More

Company:Elekta, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0112-2016 REASON Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.. RECALLING FIRM/MANUFACTURER...Read More

Company: GE Healthcare.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall...Read More