Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. Recall Number Z-1645-2014 REASON Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. RECALLING FIRM/MANUFACTURER Siemens Medical...Read More

Company: Philips Healthcare Informatics, Inc.Date of Enforcement Report 5/28/2014 Class lI: PRODUCT Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and...Read More

Company: GE Healthcare Date of Enforcement Report:5/28/2014 Class lI: PRODUCT GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only. Recall Number Z-1640-2014 REASON When...Read More