Company:Viewray Incorporated Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Treatment Planning and Delivery System Software version 3.6. ViewRay” Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-1954-2015 REASON The firm discovered that the software was failing to determine new...Read More

Company:Varian Medical Systems IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. Recall Number Z-1849-2015...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. Recall Number Z-1972-2015 REASON Siemens became aware that during...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The Rapidlab 1260 and Rapidlab 1265 systems are blood gas analyzers used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. Recall Number Rapid Lab 1260: Z-1961-2015 Rapidlab 1265 Z-1962-2015 REASON D50 and D51 Diagnostic...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular,...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT CentraLink” Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal...Read More