Company: SynCardia Systems Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 Recall Number Z-0659-2017 REASON The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 12/14/2016 Class lI: PRODUCT SOMATOM Force, System x-ray, tomography, computed Recall Number Z-0962-2017 REASON Siemens is providing software update versionVA50A_SP3 to address the software bugs thatwere identified through normal field monitoringand the Global Complaint Handling Process.Correction for the problems are as follows:1. Correction to volumetricmisrepresentations...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. Recall Number Z-0723-2017 REASON Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 12/14/2016 Class lI: PRODUCT RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning SystemProduct Usage: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 dose distributions expected during the proposed treatment, and may...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Ingenuity Core 128 728323 Computed Tomography X-ray systems Recall Number Z-0696-2017 REASON Software error due to the filament on timer. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH on 11/12/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 509...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. Recall Number Z-0726-2017 REASON Cut lines on the image may present horizontally rather than...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units,...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 12/14/2016 Class lI: PRODUCT Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-0720-2017 REASON An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 12/14/2016 Class lI: PRODUCT Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an...Read More